USFDA nod to JnJ for Rybrevant, Chemotherapy combo for lung cancer treatment

Johnson & Johnson has announced that following a priority review, the U.S. Food and Drug Administration (FDA) has approved RYBREVANT (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test.

This FDA action converts the May 2021 accelerated approval of RYBREVANT to a full approval based on the confirmatory Phase 3 PAPILLON study.

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Johnson And Johnson Gets USFDA Approval For Rybrevant, Chemotherapy Combo For Lung Cancer Treatment