Venetoclax FDA approved for CLL and SLL
On 15 May 2019, the FDA approved venetoclax (Venclexta®, AbbVie/Genentech) for the treatment of adult chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) patients.
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Ramucirumab FDA approved for hepatocellular carcinoma
On 10 May 2019, the FDA approved single agent ramucirumab (Cyramza®, Eli Lilly) for the treatment of hepatocellular carcinoma (HCC) patients previously treated with sorafenib and who have an alpha-fetoproteintein (AFP) of ≥ 400 ng/mL.
T-DM1 FDA approved for early breast cancer
On the 3rd of May 2019, the FDA approved ado-trastuzumab emtansine (Kadcyla® [T-DM1], Genentech/Roche) as adjuvant therapy for human epidermal growth factor receptor (HER2)-positive early breast cancer (EBC) patients with residual invasive disease after neoadjuvant treatment with a taxane and trastuzumab.
Ivosidenib FDA-approved as first-line treatment for AML patients with IDH1 mutation
On the 2nd of May 2 2019, the FDA approved ivosidenib (Tibsovo®, Agios) as treatment for newly-diagnosed acute myeloid leukaemia (AML) patients ≥75 years old and AML patients with comorbidities precluding intensive induction chemotherapy. Patients should harbour a susceptible IDH1 mutation, as per the FDA-approved Abbott RealTime™ IDH1 Assay, to be legible for ivosidenib treatment.
Pembrolizumab plus axitinib FDA approved for the first-line treatment of advanced renal cell carcinoma patients
On 19 April 2019, the FDA approved the programmed death 1 (PD-1) inhibitor pembrolizumab (KEYTRUDA®, Merck) plus axitinib – a selective and potent receptor tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 – as a first-line treatment for advanced renal cell carcinoma (RCC) patients.
Palbociclib approved for the treatment of male breast cancer
On 4 April 2019, the US FDA approved palbociclib (Ibrance®, Pfizer) plus aromatase inhibitor or fulvestrant for the treatment of male patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
Erdafitinib FDA approved for the treatment of metastatic urothelial carcinoma
On 12 April 2019, the FDA granted accelerated approval to erdafitinib (Balversa®, Janssen) for the treatment of locally advanced or metastatic urothelial cell carcinoma (mUCC) progressed during or following a platinum-containing regimen, including progression within 12 months of (neo)adjuvant platinum-based chemotherapy, and whose tumours harbour susceptible fibroblast growth factor receptor (FGFR) 3 or FGFR2 genetic alterations as determined by the FDA approved companion diagnostic (CDx), the therascreen® FGFR RGQ RT-PCR Kit by Qiagen.
Single-agent pembrolizumab FDA approved for the first-line treatment of stage III NSCLC with PD-L1 TPS ≥1%
On 11 April 2019, the FDA approved single-agent pembrolizumab (Keytruda®, Merck) for the first-line treatment of stage III/IV non-small cell lung cancer (NSCLC) patients with a PD-L1 Tumor Proportion Score (TPS) ≥1% who are not amenable to surgical resection or definitive chemoradiation and who have no known EGFR or ALK genomic aberrations.
Atezolizumab FDA approved for extensive-stage small cell lung cancer (SCLC)
On 18 March 2019, the FDA approved atezolizumab (Tecentriq®, Genentech) plus carboplatin and etoposide as front-line treatment of adult extensive-stage small cell lung cancer (ES-SCLC) patients.
Atezolizumab FDA approved for PD-L1 positive unresectable triple-negative breast cancer
On 8 March 2019, the FDA granted accelerated approval to atezolizumab (Tecentriq®, Genentech/Roche) in combination with albumin-bound paclitaxel (nab-paclitaxel) for the treatment of adult unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) patients with programmed death 1 ligand (PD-L1) stained tumour-infiltrating immune cells (IC) of any intensity covering ≥1% of the tumour area, as determined by the VENTANA PD-L1 (SP142) Assay companion diagnostic (CDx).
Trastuzumab/hyaluronidase-oysk subcutaneous formulation FDA approved for HER2‑overexpressing breast cancer
On 28 February 2019, the FDA approved the subcutaneous formulation trastuzumab/hyaluronidase-oysk (Herceptin Hylecta®, Genentech) for the treatment of human epidermal growth factor receptor 2 (HER2)‑overexpressing breast cancer.
Trifluridine/tipiracil combination FDA approved for metastatic gastric or GEJ adenocarcinoma
On 22 February 2019, the FDA approved the fixed combination tablets of the nucleoside metabolic inhibitor trifluridine plus the thymidine phosphorylase inhibitor tipiracil (Lonsurf®, Taiho Pharmaceutical) for the treatment of adult metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients pretreated with two or more prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan plus (when appropriate) HER2/neu-targeted therapy.
Pembrolizumab FDA approved for adjuvant treatment of melanoma
On 15 February 2019, the FDA approved pembrolizumab (Keytruda®, Merck) for the adjuvant treatment of melanoma patients with lymph node involvement following complete resection.
Trastuzumab-biosimilar Ontruzant® FDA approved in several indications
On 18 January 2019, the FDA approved the Herceptin®-biosimilar Ontruzant® (trastuzumab-dttb, Samsung BioEpsis), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer in the adjuvant and metastatic setting, and in metastatic HER2+ gastric cancer patients. Ontruzant® was approved as biosimilar, not as an interchangeable product.
Cabozantinib FDA approved in HCC patients failing sorafenib
On 14 January 2019, the FDA approved cabozantinib (Cabometyx®, Exelixis) for hepatocellular carcinoma (HCC) patients previously treated with sorafenib.
Calaspargase pegol-mknl (Asparlas®) FDA approved in paediatric and young adult acute lymphoblastic leukaemia (ALL) patients
On 20 December 2018, the FDA approved the asparagine specific enzyme calaspargase pegol-mknl (Asparlas®, Servier) as a component of multi-agent chemotherapeutic regimens for the treatment of paediatric and young adult patients aged 1 month to 21 years with acute lymphoblastic leukaemia (ALL).
Elzonris™ FDA approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN)
On 21 December 2018, the FDA approved the CD123-directed cytotoxin tagraxofusp-erzs (Elzonris™, Stemline Therapeutics), for the treatment of adult and paediatric patients of 2 years and older with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Olaparib (Lynparza) FDA approved as maintenance for BRCAm ovarian cancer
On 19 December 2018, the FDA approved olaparib (Lynparza®, AstraZeneca) as a maintenance treatment for adult advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients who achieving a complete or partial response to first-line platinum-based chemotherapy and who have deleterious germline or somatic BRCA-mutatations (gBRCAm or sBRCAm) by an FDA-aproved test or who are suspected to have deleterious BRCA-mutatations (BRCAm).
Trastuzumab-biosimilar Herzuma® FDA approved in HER2+ breast cancer
On 14 December 2018, the FDA approved the Herceptin®-biosimilar Herzuma® (trastuzumab-pkrb, Celltrion), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer. Herzuma® was approved as biosimilar, not as an interchangeable product.
Frontline atezolizumab plus bevacizumab and chemotherapy FDA approved for metastatic non-squamous NSCLC
On 6 December 2018, the FDA approved atezolizumab (Tecentriq®, Roche/Genentech) plus bevacizumab and chemotherapy with paclitaxel and carboplatin for the frontline treatment of metastatic non-squamous non-small cell lung cancer (NSq NSCLC) patients not harbouring any EGFR or ALK genomic tumour aberrations.
MURANO: off-drug progression-free survival after 2 years venetoclax plus 6 cycles Rituximab
On the first day of the 2018 American Society of Hematology (ASH) Annual Meeting, an additional year of follow-up data from the practice-changing MURANO study were presented to the audience by Professor John F. Seymour. In the trial’s setting of relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL), the non-chemo-containing regimen venetoclax (Venclexta®, AbbVie/Roche) plus rituximab was associated with maintained superior progression-free survival (PFS) and overall survival (OS) over standard-of-care chemoimmunotherapy with bendamustine plus rituximab. At the same time, a durable post-treatment disease control is also attainable with the fixed-duration chemo-free regimen.
TIGR®Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy
Onlay mesh placement of the synthetic and fully resorbable TIGR®Matrix surgical mesh (Novus Scientific AB, Uppsala — Sweden) for the prevention of incisional hernia in septic patients undergoing emergency laparoscopy showed encouraging efficacy and safety in a small retrospective study, as presented during the XXVIII Waterford Surgical October Club Meeting.
Efficacy of oral Cladribine for MS durable after a two-year treatment course
Two short courses of oral cladribine (Mavenclad®, Merck KGaA) over a period of two years can sustain the No Evidence of Disease Activity-3 (NEDA-3) status in certain relapsing-remitting multiple sclerosis (RRMS) patients for up to three additional years without further treatment, a new analysis presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2018 suggests.
Gilteritinib (Xospata®) FDA approved for relapsed or refractory AML harbouring FLT3 mutations
On 28 November 2018, the FDA approved gilteritinib (Xospata® [ASP2215], Astellas) for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukaemia (AML) harbouring FLT3 mutations as confirmed by an FDA-approved companion diagnostic test (CDx).
TKR inhibitor larotrectinib (Vitrakvi®) FDA approved for cancers with NTRK gene fusion
On 26 November 2018, the FDA granted accelerated approval to the first-in-class tropomyosin receptor-kinase (TRK) inhibitor larotrectinib (Vitrakvi®, Loxo Oncology/Bayer) for the treatment of adult and paediatric patients with solid tumours that are metastatic or not amenable to surgery, harbour the neurotrophic receptor tyrosine kinase (NTRK) gene fusion in the absence of known acquired resistance mutations, and whose cancer progressed following treatment or for whom are no satisfactory other treatment options available.
Venetoclax plus azacitidine, decitabine, or low-dose cytarabine FDA approved in elderly AML patients
On 21 November 2018, the FDA granted accelerated approval to venetoclax (Venclexta®, AbbVie/Genentech) in combination with either azacitidine, or decitabine, or low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) patients ≥75 years old or in patients with comorbidities precluding intensive induction chemotherapy.
Glasdegib plus low-dose cytarabine (LDAC) approved in elderly AML patients
On 21 November 2018, the FDA approved glasdegib (Daurismo®, Pfizer) in combination with low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) in patients of 75 years or older and in patients with comorbidities contraindicating intensive induction chemotherapy.
Emapalumab FDA approved in adult and paediatric patients with primary hemophagocytic lymphohistiocytosis
On 20 November 2018, the FDA approved the interferon-γ neutralising monoclonal antibody emapalumab (Gamifant®, Novimmune) for the treatment of adult and paediatric (newborn and older) patients with refractory, recurrent, or progressive primary haemophagocytic lymphohistiocytosis (HLH) or in patients intolerant to conventional HLH therapy.
Brentuximab vedotin (Adcetris®) plus chemotherapy approved for several CD30 expressing lymphomas
On 16 November, 2018, the FDA approved brentuximab vedotin (Adcetris®, Seattle Genetics) in combination with chemotherapy for the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL) and other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS).
Fully resorbable synthetic matrix offers improved safety for breast cancer patients undergoing immediate breast reconstruction
UPPSALA, Sweden, Nov. 21, 2018 /PRNewswire/ — Using the synthetic and fully resorbable TIGR®Matrix surgical mesh (Novus Scientific AB, Uppsala — Sweden) improves the outcome in breast cancer patients undergoing immediate reconstruction, as published in the Journal of Plastic Surgery and Hand Surgery.
PPT Download – ESMO18 HCC BTC
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PPT Download – ESMO18 NSCLC Summary
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Pembrolizumab FDA approved in hepatocellular carcinoma patients pretreated with sorafenib
On 9 November 2018, the FDA granted accelerated approval to pembrolizumab (Keytruda®, Merck) for the treatment of patients with hepatocellular carcinoma (HCC) previously treated with sorafenib.
Lorlatinib FDA approved for metastatic ALK-positive NSCLC
On November 2nd 2018, lorlatinib (LORBRENA®, Pfizer) received accelerated approval by the FDA for the second- and third-line treatment of patients with metastatic, anaplastic lymphoma kinase (ALK)-positive, non-small cell lung cancer (NSCLC). Third-line patients should have had progression on crizotinib and another ALK-inhibitor for metastatic disease, and second-line patients should have had progression on either alectinib or ceritinib in the first-line for metastatic disease.
Pembrolizumab plus chemotherapy approved for metastatic squamous NSCLC
On October 30th 2018, the FDA approved the use of programmed death 1 (PD-1) inhibitor pembrolizumab (Keytruda®, Merck) in combination with carboplatin plus paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC).
PARPi talazoparib FDA approved for deleterious gBRCAm HER2‑negative breast cancer
On October 16, 2018, the FDA approved PARP-inhibitor talazoparib (Talzenna®, Pfizer) for use in patients with deleterious or suspected deleterious germline BRCA-mutated locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Patients should be selected for the PARP inhibitor (PARPi)-treatment using an FDA-approved companion diagnostic (CDx) for talazoparib.
Anti-PD1 sintilimab plus biosimilar bevacizumab receive IND-status by China NMPA
SUZHOU, China, Oct. 14, 2018 /PRNewswire/ — The combination therapy of novel programmed death 1 (PD-1) antibody IBI308 (sintilimab, Innovent Biologics) with biosimilar bevacizumab antibody IBI305 (Innovent Biologics) has received the investigational new drug (IND) application for clinical development approval by the National Medical Products Administration (NMPA, formerly known as CFDA) in China.
IMpower133: first-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer
Atezolizumab (Tecentriq®, Roche/Genentech) plus standard chemotherapy for the first-line treatment of extensive-stage small-cell lung cancer (SCLC) was associated with a significantly longer overall survival (OS) and progression-free survival (PFS) when compared with chemotherapy alone.
Pembrolizumab plus chemotherapy effective in squamous NSCLC
Pembrolizumab (Keytruda®, Merck) in combination with chemotherapy was associated with longer overall survival (OS) and progression-free survival (PFS) when compared to placebo plus chemotherapy in patients with untreated metastatic squamous cell non-small cell lung cancer (NSCLC).
Ipilimumab plus nivolumab for persistent or recurrent ovarian cancer
Adding ipilimumab (IPI [Yervoy®, Bristol-Myers Squibb]) to nivolumab (NIVO [Opdivo®, Bristol-Myers Squibb]) induction followed by maintenance with single-agent NIVO had a superior objective tumour response rate and progression-free survival (PFS) when compared to NIVO alone in patients with persistent or recurrent epithelial ovarian cancer.
Brigatinib prolongs PFS compared to crizotinib in ALK-Positive NSCLC
Brigatinib (Alunbrig®, Ariad) significantly prolongs the progression-free survival (PFS) in anaplastic lymphoma kinase (ALK) inhibitor-naïve patients with ALK-rearranged non-small cell lung cancer (NSCLC) when compared to crizotinib, as resulted from the ALTA-1L study.
CAR-T axicabtagene ciloleucel granted Orphan Drug designation for B-Cell Lymphoma by the Japan MHLW
TOKYO and BASKING RIDGE, N.J., October 3, 2018 /PRNewswire/ — The Japan Ministry of Health, Labour and Welfare (MHLW) granted the Orphan Drug designation to axicabtagene ciloleucel (KTE-C19, Daiichi Sankyo) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL), and transformed follicular lymphoma (TFL), which are all aggressive forms of non-Hodgkin lymphoma (NHL).
PD-1 mAB cemiplimab FDA approved for locally advanced and metastatic cutaneous squamous cell carcinoma (CSCC)
On September 28, 2018, the FDA approved programmed death 1 (PD-1) immune-checkpoint inhibitor cemiplimab-rwlc (Libtayo®, Regeneron) for use in patients with metastatic cutaneous squamous cell carcinoma (CSCC) and patients with locally advanced CSCC unamenable for curative surgery or curative radiation.
JAVELIN Lung 200: avelumab vs docetaxel for pretreated NSCLC
Avelumab (Bavencio®, Merck KGaA) does not improve the overall survival (OS) in non-small cell lung cancer (NSCLC) patients previously treated with platinum-doublet chemotherapy, as resulted from the JAVELIN Lung 200 study (NCT02395172). The safety profile favoured avelumab over docetaxel.
Dacomitinib FDA approved for the first-line treatment of metastatic EGFR-mutated NSCLC
On September 27, 2018, the FDA approved dacomitinib (Vizimpro®, Pfizer) as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R mutations as confirmed by an FDA-approved test.
Transcatheter aortic valve replacement reduces severe aortic stenosis in real-world study
Transcatheter aortic valve replacement (TAVR) with the Portico® valve (Abbott) was found to be safe and associated with low rates of stroke, death or paravalvular leakage at one-year follow-up, according to the real-world PORTICO I study in patients with symptomatic, severe aortic stenosis.
Transcatheter- vs surgical aortic valve replacement in high-risk patients: 5-years survival
Transcatheter aortic valve replacement (TAVR) with the CoreValve® system (Medtronic) and surgical aortic valve replacement (SAVR) show similar 5-year survival and stroke rates in high-risk patients, as shown by the MCV-US-2009-01 study (NCT01240902). Most patients remained free from severe structural valve deterioration (SVD) and valve reinterventions (VR).
Duvelisib FDA approved for adult patients with R/R CLL or SLL
On September 24, 2018, the US FDA granted regular approval to duvelisib (Copiktra®, Verastem) for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) after ≥2 prior therapies.
Duvelisib FDA approved for adult patients with R/R follicular lymphoma
On September 24, 2018, the US FDA granted accelerated approval to duvelisib (Copiktra®, Verastem) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after ≥2 prior therapies.
Frontline atezolizumab plus chemotherapy improves PFS in NSCLC
An interim analysis of the Phase III IMpower132 study showed that atezolizumab (Tecentriq®, Roche/Genentech) plus platinum-based chemotherapy (cisplatin or carboplatin) with pemetrexed improves the median progression-free survival (PFS) in treatment-naïve patients with non-squamous non-small cell lung cancer (NSCLC). The median PFS for atezolizumab plus pemetrexed and a platinum salt was 7.6 months vs 5.2 months with chemotherapy alone (HR=0.60, 95% CI: 0.49-0.72; p<0.0001).
Early breast cancer treatment in China remains conservative
Breast-conserving surgery is uncommon in China, and despite routinely performing SLNB the uptake of the ACOSOG Z0011 study recommendation to treat selected sentinel node-positive patients with whole breast irradiation and adjuvant systemic therapy instead of ALND remains low at only 17% of Chinese centres. These were the key findings of a national survey among 520 Chinese hospitals.
Anti-coagulation: impact on long-term mortality and early valve dysfunction
Anticoagulation, which is often provided for atrial fibrillation (AF), decreases the risk of bioprosthetic valve dysfunction (BVD) after transcatheter aortic valve replacement (TAVR), according to the results of the FRANCE-TAVI registry study. Male gender, chronic kidney disease (CKD), and atrial fibrillation (AF) have the highest impact on the 3-year mortality due to BVD after TAVR.
Camrelizumab anti-PD-1 with or without chemotherapy for NPC
Camrelizumab (SHR-1210, Hengrui Medicine), a novel programmed death 1 (PD-1) inhibitor, plus gemcitabine and cisplatin showed a manageable toxicity profile with promising, preliminary anti-tumour activity in treatment-naïve Chinese nasopharyngeal carcinoma (NPC) patients. Larger, randomised controlled trials may provide further insight into the role of anti-PD1 for NPC, wrote the authors in the Lancet Oncology.
Moxetumomab pasudotox-tdfk FDA approved for hairy cell leukaemia
On September 13, 2018, the FDA approved moxetumomab pasudotox-tdfk (Lumoxiti®, AstraZeneca) for adult patients with relapsed or refractory (R/R) hairy cell leukaemia (HCL) who had received at minimum two prior systemic therapies, of which one a purine nucleoside analogue (PNA).
Venetoclax FDA label updated to include Minimal Residual Disease negativity data
On the 11th of September 2018, the FDA updated the label of venetoclax tablets (VENCLEXTA®, Abbvie) in combination with rituximab (MabThera®, Roche) to include information about pre-treated patients with chronic lymphocytic leukemia (CLL) in the Phase III MURANO trial who had achieved Minimal Residual Disease (MRD)-negativity.
Quizartinib receives Orphan Drug designation for FLT3-mutated AML in Japan
TOKYO and MUNICH and BASKING RIDGE, N.J., September 11, 2018 — The Japan Ministry of Health, Labour and Welfare (MHLW) has granted quizartinib (AC220, Daiichi Sankyo), an investigational inhibitor of FLT3, the Orphan Drug designation for the treatment of acute myeloid leukaemia (AML) harbouring FLT3-mutations.
Capmatinib plus gefitinib promising in MET-dysregulated NSCLC
The combination capmatinib (INC280, Novartis) plus gefitinib (Iressa®, AstraZeneca) showed promising, early phase efficacy in patients with mesenchymal-epithelial transition factor (MET)-dysregulated and epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
CAR-TCR Summit 2018: Preliminary first-in-human data with CAR-Claudin18.2-T in gastric and pancreatic cancer
CARsgen Therapeutics, a Shanghai-based clinical-stage immune-oncology company committed to developing Chimeric Antigen Receptor T (CAR-T) cell therapies for cancer, presented preliminary data of their first-in-class CAR-Claudin18.2 T-cell clinical trial in pancreatic and gastric cancer patients during the 2018 CAR-TCR Summit in Boston.
DRIVER connects cancer patients in China and the United States to the best care
SAN FRANCISCO and SHANGHAI, Sept. 6, 2018/PRNewswire/ — Today, Driver, a global technology platform that connects cancer patients to the best treatments, launches in the United States and China. Driver’s platform enables any patient, anywhere in the world, to access treatment options across an unprecedented network of cancer centres without leaving home.
Plasma TMB predicts response to atezolizumab in NSCLC patients
A high tumour mutational burden in the plasma (bTMB) is a clinically actionable biomarker for atezolizumab (Tencentriq®, Roche) treatment in patients who failed 1st-line platinum-based therapy for advanced non-small cell lung cancer (NSCLC).
Edoxaban in Asian patients with atrial fibrillation: effectiveness and safety
Real-life use of edoxaban (Lixiana®, Daiichi Sankyo) in Asian atrial fibrillation (AF) patients significantly lowered the risk of ischaemic stroke (IS), intracranial haemorrhage (ICH), hospitalisation for gastrointestinal (GI) bleeding, hospitalisation for major bleeding, and all-cause death when compared to warfarin. This was concluded by the Korean investigators in the Journal of the American College of Cardiology. The benefits were consistent in the various high-risk subgroups.
Febuxostat prevents CV events in hyperuricaemia patients
Febuxostat to decrease uric acid levels and aid the prevention of cerebral, cardiovascular and renal events in elderly hyperuricaemia patients as reported by the investigators of the FREED trial during the ESC 2018 Congress.
First-in-Class Oncology Vaccine BIL06v Starts Phase 1 Evaluation
Biosceptre has announced the initiation of its Phase 1 clinical study with the peptide vaccine BIL06v. BIL06v is a peptide-protein conjugate that recruits the patient’s immune system to make antibodies specifically targeted at nfP2X7-expressing cancer cells resulting in tumour cell death.
Pembrolizumab and atezolizumab USPIs updated by FDA
On the 16th of August, 2018, the FDA updated the prescribing information for pembrolizumab (Keytruda®, Merck) and atezolizumab (Tecentriq®, Roche/Genentech) and added the requirement for the use of an FDA-approved companion diagnostic test (CDx) to determine PD-L1 levels in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.
Nivolumab FDA approved for patients with metastatic small cell lung cancer (SCLC)
On the 16th of August 2018, the FDA granted accelerated approval to nivolumab (Opdivo®, Bristol-Myers Squibb) for use in patients with metastatic small cell lung cancer (SCLC) who progressed after two lines of therapy, including one line of platinum-based chemotherapy.
Pembrolizumab plus pemetrexed-platinum FDA approved for first-line treatment of metastatic non-squamous NSCLC
On 20th of August 2018, the FDA granted regular approval for pembrolizumab (Keytruda®, Merck) plus pemetrexed and a platinum salt in the first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSCLC), not harbouring any EGFR or ALK genomic tumour aberrations.
Talazoparib in advanced breast cancer patients with a germline BRCA1/2 mutation
Single-agent PARP-inhibition with talazoparib is associated with an improved progression-free survival (PFS) and better patient-reported outcomes (PRO) when compared to chemotherapy alone in patients with advanced breast cancer (ABC) and a germline BRCA1/2 mutation, as reported by the investigators of the Phase III EMBRACA study (NCT01945775) in the New England Journal of Medicine.
CheckMate 032: Nivolumab +/- ipilimumab for metastatic esophagogastric cancer
Immunotherapy with either nivolumab (Opdivo®, Bristol-Myers Squibb) alone or the combination nivolumab plus ipilimumab (Yervoy®, Bristol-Myers Squibb) in patients with chemotherapy-refractory esophagogastric cancer leads to durable responses and encouraging long-term overall survival with a manageable safety profile, concluded the investigators of the CheckMate 032 study.
Lenvatinib FDA approved for 1st-line treatment of HCC
On August 16, 2018 the FDA approved lenvatinib (Lenvima®, Eisai) for the first-line treatment of hepatocellular carcinoma (HCC) patients not amenable for curative surgery.
PolyU Researchers Develop Novel Self-fitting Scaffold for Bone-Regeneration
HONG KONG, August 15, 2018 /PRNewswire/ — A group of researchers from the Hong Kong Polytechnic University (PolyU) in close collaboration with Sichuan University have successfully designed and manufactured a novel bone scaffold that can be safely implanted into bone defects, induce bone-regeneration, and enhance the recovery of bone injuries and fractures.
Pan-EGFR TKI pirotinib has commenced into Phase II clinical testing in China
HONG KONG, CHINA – 13 August 2018 – Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460), announced that its innovative in-house developed oncology drug pirotinib has commenced into Phase II Clinical testing in China following the completion of a Phase I clinical trial in three renowned cancer research centres in the United States.
FDA approved mogamulizumab for adult patients with relapsed or refractory CTCL
On the 8th of August 2018, the FDA approved mogamulizumab-kpkc (Poteligeo®, Kyowa Kirin), a CC chemokine receptor type 4 (CCR4) directed monoclonal antibody, for use in adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL).
Lusutrombopag FDA approved for thrombocytopenia in adult chronic liver disease patients
On the 31st of July 2018, the FDA approved lusutrombopag (Mulpleta®, Shionogi) for thrombocytopenia in adult chronic liver disease (CLD) patients scheduled for an invasive medical or dental procedure.
Iobenguane I-131 FDA approved for rare adrenal neuroendocrine tumours
On July 30, 2018, the FDA approved iobenguane I-131 (Azedra®, Progenics Pharmaceuticals), a radioactive therapeutic agent, for the treatment of adult and paediatric patients ≥12 years with iobenguane scan positive, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) not amenable to surgery and indicated for systemic therapy.
Osimertinib in patients with T790M-positive advanced non-small cell lung cancer and brain metastases (AURA3)
Osimertinib is active in the second-line treatment of patients with T790M-positive advanced non-small cell lung cancer (NSCLC) and central nervous system (CNS) metastases, as reported by the investigators of the Phase III AURA3 study.
Standard- and low-dose rivaroxaban in Asians with AF: Effectiveness and Safety
In Asian atrial fibrillation (AF) patients, low-dose rivaroxaban (Xarelto®, Bayer) has a similar effect on the risk of thromboembolism and bleeding but not on myocardial infarction (MI) when compared to the standard-dose, as shown in a retrospective population-based cohort study from Taiwan.
Anti-PD1 with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma
Programmed death 1 (PD-1) inhibition with the novel human anti-PD1 monoclonal antibody cemiplimab (REGN2810, Regeneron and Sanofi) in patients with locally advanced or metastatic cutaneous squamous-cell carcinoma (CSCC) resulted in a response in approximately half of the patients.
Ivosidenib FDA approved for relapsed or refractory acute myeloid leukemia
On July 20, 2018, the US FDA approved ivosidenib (Tibsovo©, Agios Pharmaceuticals) for use in adult patients with relapsed or refractory acute myeloid leukaemia (AML) harbouring a susceptible IDH1 mutation as detected by an FDA-approved companion diagnostic (CDx) test, the Abbott RealTime IDH1 Assay.
Filgrastim-aafi FDA approved as Filgrastim Biosimilar
On July 20, the FDA approved filgrastim-aafi (Nivestym®, Pfizer), as a biosimilar to filgrastim (Neupogen, Amgen). The label includes all indications of the reference product.
Ribociclib FDA label updated to include pre- and perimenopausal women
On July 18, 2018, the US FDA expanded the ribociclib (Kysqali©, Novartis) approval. Ribociclib plus an aromatase inhibitor as initial endocrine-based therapy is no longer limited to postmenopausal HR-positive, HER2-negative advanced or metastatic breast cancer patients alone and now includes pre- and perimenopausal women. Furthermore, the FDA has added the combination ribociclib plus fulvestrant as initial endocrine-based therapy for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.
Enzalutamide FDA approved for castration-resistant prostate cancer (CRPC)
On July 13, the FDA approved enzalutamide (Xtandi©, Astellas), for use in patients with castration-resistant prostate cancer (CRPC).
EBV, MSI, and CPS predict pembrolizumab outcome in gastric cancer
Metastatic gastric cancer (mGC) patients with microsatellite instability-high (MSI-H) or Epstein-Barr virus (EBV)-positive tumours, or those with a positive (≥1%) combined positive score (CPS) respond best to pembrolizumab PD-1 immunotherapy.
Ipilimumab plus nivolumab FDA approved for MSI-H and dMMR pre-treated mCRC
On July 10th, the FDA granted accelerated approval to ipilimumab (Yervoy©, Bristol-Myers Squibb) for use in combination with nivolumab (Opdivo©) for the treatment of adult and paediatric patients ≥12 years of age with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Combination encorafenib plus binimetinib for unresectable/metastatic BRAF V600E or V600K-positive melanoma FDA approved
On June 27th, the FDA approved Array Biomarpharma’s combination encorafenib (BRAFTOVI®) plus binimetinib (and MEKTOVI®) for patients with unresectable or metastatic melanoma harbouring a BRAF V600E or V600K mutation detected by an FDA-approved test.
FDA limits use of atezolizumab and pembrolizumab in urothelial carcinoma
On June 19, the FDA limited the use of atezolizumab and pembrolizumab for the treatment of locally advanced or metastatic urothelial cancer patients ineligible for cisplatin-containing therapy.
Bevacizumab in combination with carboplatin and paclitaxel FDA approved for several types of gynaecological cancers
On June 13, 2018, the FDA approved bevacizumab (AvastinⓇ, Genentech, Inc.) in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab for use after surgical resection in patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer.
FDA approved pembrolizumab for 3rd-line PMBCL in adult and pediatric patients
On June 13, 2018, the US FDA has granted accelerated approval to pembrolizumab (Keytruda, Merck & Co) for the treatment of adult and pediatric patients with primary mediastinal large B-cell lymphoma (PMBCL), relapsed after two or more prior lines of prior therapy.
FDA approved pembrolizumab for chemotherapy-refractory r/m cervical cancer with PD-L1 CPS ≥1
On June 12, 2018 the FDA approved pembrolizumab (KeytrudaⓇ, Merck & Co. Inc.) for patients with chemotherapy-refractory recurrent or metastatic (r/m) cervical cancer and with a combined positive score (CPS)≥1 PD-L1 level expression.
FDA approves venetoclax in 2nd-line for patients with CLL or SLL
FDA granted regular approval to venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
FDA approved biosimilar pegfilgrastim to decrease the chance of febrile neutropenia in patients with non-myeloid cancers on myelosuppressive chemotherapy
FDA approved Fulphila (pegfilgrastim-jmdb, Mylan GmbH), a biosimilar of Neulasta (pegfilgrastim, Amgen, Inc.) to decrease the chance of infection due to febrile neutropenia in patients receiving myelosuppressive chemotherapy with clinically significant incidence of febrile neutropenia and with non-myeloid cancers
FDA approved avatrombopag for thrombocytopenia in CLD patients scheduled for a procedure
On May 21, the FDA approved avatrombopag (DopteletⓇ, AkaRx Inc.) for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) scheduled to undergo a procedure.
Biosimilar epoetin alfa-epbx approved by FDA for the treatment of anemia due to chronic kidney disease, use of zidovudine for HIV, and concomitant myelosuppressive chemotherapy
On May 14, 2018 the FDA announced approval of biosimilar epoetin alfa-epbx (Retacrit®, Hospira, a subsidiary of Pfizer) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. Epoetin alfa-epbx is also […]
FDA approves dabrafenib plus trametinib for anaplastic thyroid cancer with BRAF V600E mutation
FDA approves dabrafenib plus trametinib for anaplastic thyroid cancer with BRAF V600E mutation. More Information. May 4, 2018.
Tisagenlecleucel CAR-T receives additional FDA Approval for DLBCL
Tisagenlecleucel CAR-T receives additional FDA Approval for DLBCL FDA approved tisagenlecleucel (KYMRIAH, Novartis Pharmaceuticals Corp.) a CD19-directed genetically modified autologous T-cell immunotherapy, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL […]
Adjuvant dabrafenib plus trametinib FDA approved for BRAF V600E or V600K melanoma
The FDA granted regular approval to dabrafenib (Tafinlar®, Novartis) and trametinib (Mekinist®, Novartis) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
FDA approved osimertinib for the 1st-line treatment of patients with EGFR exon 19 deletions or exon 21 L858R mutations positive metastatic non-small cell lung cancer (NSCLC)
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FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Frontline nivolumab plus ipilimumab approved for intermediate or poor risk advanced RCC
The FDA granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.
Everolimus suspension approved in TSC-associated partial-onset seizures
On April 10, the FDA approved everolimus tablets for oral suspension (Afinitor Disperz®, Novartis) for the adjunctive treatment of adult and pediatric patients ≥2 years with tuberous sclerosis complex (TSC)-associated partial-onset seizures.
FDA approved rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer
FDA approved rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer. More Information.
Interest Builds in CSF1R for Targeting Tumor Microenvironment
A growing appreciation of the role of the tumor microenvironment in fostering the development of malignancies is prompting the pursuit of anticancer therapies that target components of this supportive niche as opposed to the tumor itself. Read full article (External website)