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New Indication for Amivantamab OK’d

March 1, 2024

The FDA approved amivantamab (Rybrevant; Janssen Biotech) in combination with carboplatin and pemetrexed as a first-line treatment for locally advanced or metastatic non–small cell lung cancer with EGFR exon 20 insertion mutations as detected by an FDA-approved test. The agency also granted full approval to the bispecific antibody to treat adults with the condition whose disease progressed while on or after platinum-based chemotherapy. In the phase III PAPILLON trial, patients who received the trio of drugs had a median progression-free survival of 11.4 months compared with 6.7 months among those who received just carboplatin and pemetrexed.

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