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# Janssen Files sBLA for Expanded Rybrevant
- URL: https://www.fdaweb.com/janssen-files-sbla-for-expanded-rybrevant/
- Published: 2023-08-28T12:00:00.000Z
- Updated: 2026-09-14T18:53:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155187

Janssen Pharmaceutical has submitted a supplemental BLA seeking an expanded approval for Rybrevant (amivantamab-vmjw) — combination use with chemotherapy (carboplatin-pemetrexed) as a first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The therapy was originally granted an accelerated approved 5/2021 as a single agent for treating adult patients with the same disease characteristics.

The sBLA is supported by data from the Phase 3 PAPILLON ([NCT04538664](https://classic.clinicaltrials.gov/ct2/show/NCT04538664?ref=fdaweb.com)) clinical trial. “PAPILLON is the first randomized Phase 3 study in patients with NSCLC with EGFR exon 20 insertion mutations to show clinically meaningful results,” the company says. “This creates an opportunity to make a significant improvement to the standard of care for this patient population with high unmet medical need.”