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FDA Approves Amivantamab First-line Indication for NSCLC
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 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 sworcester@mdedge.com or on X (formerly Twitter) @SW_MedReporter.
