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FDA Approval Sought for Amivantamab Plus Chemo in EGFR Exon 20 Insertion+ NSCLC

*August 2023*

A supplemental biologics license application (sBLA) seeking the expanded approval of amivantamab-vmjw (Rybrevant) in combination with carboplatin plus pemetrexed for use in the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations has been submitted to the FDA.1


The sBLA is based on findings from the phase 3 PAPILLON trial (NCT04538664), which met its primary end point when the combination resulted in a statistically significant and clinically meaningful improvement in progression-free survival (PFS) vs carboplatin/pemetrexed alone in this patient population.2 The toxicity profile of the regimen was noted to be comparable to what has been reported with each agent alone.


In May 2021, the FDA granted accelerated approval to amivantamab for use in adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease progressed on or following platinum-based chemotherapy.3 In the phase 1 CHRYSALIS trial (NCT02609776), amivantamab (n = 81) elicited an overall response rate (ORR) of 40% (95% CI, 29%-51%) by blinded independent central review and RECIST v1.1 criteria, with a median duration of response of 11.1 months (95% CI, 6.9-not evaluable).

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