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FDA Approves Janssen's Rybrevant, Chemo in Frontline NSCLC With EGFR Exon 20 Insertions

NEW YORK – The US Food and Drug Administration on Friday approved Janssen's EGFR inhibitor Rybrevant (amivantamab) plus chemotherapy as a first-line treatment for patients with advanced non-small cell lung cancer whose tumors harbor EGFR exon 20 insertion mutations.

The approval is based on results of the Phase III PAPILLON trial in which 308 patients were randomized to receive either Rybrevant plus the chemotherapy drug combination carboplatin and pemetrexed, or the chemo drugs alone.

Patients who received the Rybrevant-chemo combination lived a median 11.4 months without their cancers progressing, whereas patients who only received chemo lived a median 6.7 months without their cancers progressing. Although overall survival analyses were not mature at the time of data cutoff, the FDA in its approval announcement noted "no trend towards a detriment" in survival with the Rybrevant-chemo regimen.

Separately on Friday, the agency also converted an accelerated approval into a full approval for Rybrevant in previously treated NSCLC patients with EGFR exon 20 insertions. The FDA had granted Rybrevant monotherapy accelerated approval in this setting in May 2021, at which time it also approved Guardant Health's liquid biopsy assay Guardant360 CDx to identify patients with EGFR exon 20 insertion mutations eligible for Rybrevant.