US FDA approved CAR-T cell and BiTE immunotherapy – Updated 2-May-2018 – Medical Writer Agency | 醫學作家香港 | 醫學寫作 | MediPR

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U.S. FDA APPROVED IMMUNOTHERAPIES

CD19-DIRECTED T-CELL IMMUNOTHERAPY: CAR-T AND BiTE

Medical writer: Stijn van den Borne, MSc | Last updated: 2nd May 2018 | In: Haematology, ImmunoOncology, Immunotherapy, Oncology

Article Keywords

ALL, Amgen, axicabtagene ciloleucel, BCL, BiTE, blinatumomab, Blincyto, CAR-T, CD19, CD3, DAR-T, DLBCL, Gilead Sciences, Immunotherapy, Kite Pharmaceuticals, Kymriah, non-Hodgkin, Novartis, Oncology News, paediatric, tisagenlecleucel, Yescarta

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APPROVED CAR-T and BiTE IMMUNOTHERAPIES

The year 2017 marked another milestone in the development of immunotherapy in cancer. Two genetically modified autologous T-cell immunotherapies directed against CD19, better known as chimeric antigen receptor T-cell or CAR-T cell therapies, were approved by the United States Food and Drug Administration (U.S. FDA). One drug was tisagenlecleucel (KYMRIAH®, Novartis) and the other axicabtagene ciloleucel (YESCARTA®, Kite Pharmaceuticals/Gilead Sciences).

The first CD19-directed immunotherapy was approved in 2014 by the U.S. FDA: blinatumomab (Blincyto®, Amgen). Although blinatumomab is not a genetically modified autologous T-cell therapy, its mechanism of action is rather similar, namely linking the T-cell to the CD19+ cancerous cell. Blinatumomab is a bispecific T-cell engager (BiTE): a synthetic double-edged sword among the antibodies. The BiTE links up the V_H and V_L of two antibodies – one directed against CD19, the other against CD3 – enabling it to link the CD3+ T-cell to the CD19+ cancer cell.

Previously, we have posted on the U.S. FDA approved immune-checkpoint inhibitors. This article provides an overview of the currently approved CD19-directed therapies, the indications, and the side-effects?

The following information is based on the U.S. FDA approved package inserts and complete as of 2nd May 2018. Countries other than the U.S. may have variations in approvals as to the overview in this article.

Patients with questions regarding their disease and treatment options are strongly encouraged to discuss these with their treating physician. Physicians are recommended to always refer to the latest U.S. FDA prescribing information for approved immunotherapies.

US FDA approved CAR-t cell BiTE DAR-T cell CD19 Immunotherapies Blincyto Yescarta Kymriah

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Approved immunotherapies: CAR-T and BiTE

AXICABTAGENE CILOLEUCEL (YESCARTA®)

Axicabtagene ciloleucel (Yescarta®) is a CD19-directed genetically modified autologous T-cell (or chimeric antigen receptor T-cell [CAR-T]) immunotherapy. Axicabtagene ciloleucel (Yescarta®) is indicated for:

Note on Boxed Warnings

WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGICAL TOXICITIES.

Refer to full prescribing information for complete boxed warning.

The treatment of adult patients with relapsed or refractory large B-cell lymphoma (DLBCL) not otherwise specified pre-treated with at least two prior lines of systemic therapy including:
- Primary mediastinal large B-cell lymphoma;
- high-grade B-cell lymphoma;
- DLBCL arising from follicular lymphoma;
- Limitation: patients with primary central nervous system lymphoma excluded from label.
Most common side-effects (≥20% of patients) associated with the use of axicabtagene ciloleucel (Yescarta®) are cytokine release syndrome, fever (pyrexia), low blood pressure (hypotension), diminished brain functioning (encephalopathy), increased heart-rate (tachycardia), tiredness (fatigue), headache, decreased appetite, chills, diarrhoea, low white blood cell (neutrophil) count with fever (febrile neutropenia), infections (pathogen unspecified), nausea, oxygen deficiency (hypoxia), quivers (tremor), cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

TISAGENLECLEUCEL (KYMRIAH®)

Tisagenlecleucel (Kymriah®) is a CD19-directed genetically modified autologous T cell (or chimeric antigen receptor T-cell [CAR-T]) immunotherapy. Tisagenlecleucel (Kymriah®) is indicated for:

Note on Boxed Warnings

WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGICAL TOXICITIES.

Refer to full prescribing information for complete boxed warning.

The treatment of B-cell precursor acute lymphoblastic leukaemia (ALL) that is refractory or in second or later relapse in patients up to 25 years of age.
The treatment of adult patients with relapsed or refractory large B-cell lymphoma (DLBCL) not otherwise specified pre-treated with at least two prior lines of systemic therapy including:
- Primary mediastinal large B-cell lymphoma;
- high-grade B-cell lymphoma;
- DLBCL arising from follicular lymphoma;
- Limitation: patients with primary central nervous system lymphoma excluded from label.
Most common side-effects (≥20% of patients) associated with the use of tisagenlecleucel (KYMRIAH®):
- Pediatric and Young Adult B-cell ALL (up to 25 years of age): cytokine release syndrome, immune disorder characterised by reduced antibodies and other gamma globulins (hypogammaglobulinemia), infections (pathogen unspecified), fever (pyrexia), decreased appetite, headache, diminished brain functioning (encephalopathy), low blood pressure (hypotension), bleeding episodes, increased heart-rate (tachycardia), nausea, diarrhoea, vomiting, viral infectious disorders, oxygen deficiency (hypoxia), fatigue, acute kidney injury, excess watery fluid collection in the cavities or tissues of the body (oedema), cough, and acute disturbed state of mind (delirium).
- Adult Relapsed or Refractory DLBCL: cytokine release syndrome, infections (pathogen unspecified), fever (pyrexia), diarrhoea, nausea, tiredness (fatigue), low blood pressure (hypotension), excess watery fluid collection in the cavities or tissues of the body (oedema), and headache. (6)

BLINATUMOMAB (BLINCYTO®)

Blinatumomab (Blincyto®) is a bispecific CD19-directed CD3 T-cell engager (bispecific T-cell engager [BiTE]). Blinatumomab (Blincyto®) is indicated for:

Note on Boxed Warnings

WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGICAL TOXICITIES.

Refer to full prescribing information for complete boxed warning.

The treatment of children and adults with B-cell precursor acute lymphoblastic leukaemia (ALL) in first or second complete remission with MRD (minimal residual disease) ≥0.1%.
Relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
Most common side-effects (≥20% of patients) associated with the use of blinatumomab (Blincyto®) are”
Infections (bacterial and pathogen unspecified), fever (pyrexia), headache, infusion-related reactions, insufficient red blood cells (anaemia), low white blood cell (neutrophil) count with fever (febrile neutropenia), low blood-platelet count (thrombocytopenia), and low white blood cell (neutrophil) count (neutropenia).

REFERENCES

1. Prescribing information axicabtagene ciloleucel (Yescarta®), revised: UNK/2017
2. Prescribing information tisagenlecleucel (Kymriah®), revised: 05/2018
3. Prescribing information blinatumomab (Blincyto®), revised: 03/2018

Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).

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[…] granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and paediatric patients with B-cell precursor […]

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25th July 2018 at 3:06 PM

[…] 18 October 2017, the FDA granted regular approval to CAR-T axicabtagene ciloleucel (Yescarta®, Kite Pharma) for the treatment of adult patients with relapsed or refractory large […]

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24th May 2018 at 9:37 AM

[…] such as the immune-checkpoint inhibitors, chimeric antigen receptor T-cell (CAR-T cell) therapies, bispecific T-cell engagers (BiTE), and vaccines, have revolutionised the treatment of cancer over […]

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CD19-DIRECTED T-CELL IMMUNOTHERAPY: CAR-T AND BiTE

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APPROVED CAR-T and BiTE IMMUNOTHERAPIES

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Approved immunotherapies: CAR-T and BiTE

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TISAGENLECLEUCEL (KYMRIAH®)

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REFERENCES

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