The US Food and Drug Administration (FDA) has granted new approvals for the use of amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) in certain patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Specifically, the FDA approved the first-line use of the agent in combination with carboplatin and pemetrexed in patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.
The FDA also granted traditional approval for use in these patients after their cancer has progressed on or following platinum-based chemotherapy. The original accelerated approval for this indication occurred in 2021. At that time, the FDA also approved Guardant360® CDx (Guardant Health, Inc.) as a companion diagnostic test for amivantamab-vmjw.
The first-line approval, which followed priority review, was based on the randomized, open-label PAPILLON trial, which revealed a statistically significant improvement in progression-free survival (PFS) among the 153 patients who received amivantamab-vmjw plus carboplatin and pemetrexed vs the 155 who received the chemotherapy combination alone. Median PFS was 11.4 months in the amivantamab-vmjw arm vs 6.7 months in the control arm (hazard ratio, 0.40).
Data for overall survival, a key secondary endpoint of the study, were immature at the time of the latest analysis, but “no trend toward a detriment was observed,” according to an FDA approval announcement.
Common adverse reactions, occurring in at least 20% of patients in the study, were rash, nail toxicity, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea, and vomiting. Weight-based dosing guidance can be found in the full prescribing information.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at [email protected] or on X (formerly Twitter) @SW_MedReporter.
Source link : https://www.medscape.com/viewarticle/fda-approves-amivantamab-first-line-indication-nsclc-2024a100044m?src=rss
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Publish date : 2024-03-04 10:22:33
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