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Janssen Seeking Rybrevant-Chemo FDA Approval in First-Line NSCLC

NEW YORK – Janssen on Friday said it has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration seeking to expand the approval for Rybrevant (amivantamab) plus chemotherapy as a first-line treatment for patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations.

The firm submitted data from the Phase III PAPILLON trial, which met its primary endpoint and showed that the Rybrevant-chemo combination improved progression-free survival compared to just chemo in patients newly diagnosed with advanced or metastatic, EGFR exon 20-mutated NSCLC.

With this data, Janssen is hoping to not only expand the use of its EGFR/MET antibody in an earlier-line indication, but also "satisfy the regulatory requirements of the accelerated approval confirming the clinical benefit observed in the Phase I CHRYSALIS study," the company said in a statement.

The FDA, in May 2021, granted accelerated approval to single-agent Rybrevant for treating advanced NSCLC patients with EGFR exon 20 insertion mutations after progression on platinum-based chemo based on data from the CHRYSALIS trial. At the time, the agency also approved Guardant Health's Guardant360 CDx as a test for identifying patients with EGFR exon 20 insertion mutations who were eligible for treatment.

Janssen said last month it will report the full results from the PAPILLON at an upcoming medical meeting.