FDA Okays J&J's RYBREVANT For Advanced Non-Small Cell Lung Cancer In Combination With Chemotherapy

(RTTNews) - Johnson & Johnson (JNJ) announced that the U.S. Food and Drug Administration approved RYBREVANT (amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer or NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).

The approval is based on compelling safety and efficacy from the Phase 3 MARIPOSA-2 study, marking the third new indication for RYBREVANT® this year, with four indications overall.

On August 20, 2024, the U.S. FDA approved RYBREVANT in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or L858R substitution mutations.

On March 1, 2024, the U.S. FDA approved RYBREVANT in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.