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Lorlatinib FDA approved for the treatment of patients with metastatic ALK-positive NSCLC
By: News Feed | Last updated: 6th November 2018 | In: Lung Cancer, Oncology, Targeted Therapies, US FDA Onc\Haem Approvals
Article Keywords
alectinib, ceritinib, crizotinib, FDA, Lorbrena, lorlatinib, lymphoma, NSCLC, Pfizer
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.
Study B7461001
The Phase I/II non‑randomised, dose-ranging and activity-estimating, multi‑cohort, multicenter study B7461001 (NCT01970865) included a subgroup of 215 ALK-positive metastatic NSCLC patients pretreated with one or more ALK-inhibitors. The Phase II part’s major efficacy measures included the overall response rate (ORR) and intracranial ORR (RECIST 1.1) by independent review committee (IRC).
A 48% (95% CI, 42-55) ORR was observed, which included 4% complete (CR) and 44% partial responses (PR) with an estimated median response duration of 12.5 months (95% CI, 8.4-23.7). In the 89 patients with measurable central nervous system lesions, 21% CR and 38% PR were observed, resulting in an intracranial ORR by RECIST 1.1 of 60% (95% CI, 49-70). The estimated median intercranial response duration was 19.5 months (95% CI, 12.4-not reached).
Safety
Common adverse reactions that occurred ≥20% in patients treated with lorlatinib included oedema, peripheral neuropathy, cognitive effects, dyspnoea, fatigue, weight gain, arthralgia, mood effects, and diarrhoea. Hypercholesterolaemia and hypertriglyceridaemia were the most common laboratory abnormalities.
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).
© Copyright 2018 MediPaper Medical Communications Ltd.
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