Janssen Files sBLA for Expanded Rybrevant

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) 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.”