Expanded approval request filed with FDA for Rybrevant in non-small cell lung cancer EGFR.- Janssen Pharma

The sBLA is being reviewed by the FDA through the Real-Time Oncology Review (RTOR) program.

The sBLA is supported by data from the Phase III PAPILLON (NCT04538664) clinical trial, a randomized, open-label study evaluating the efficacy and safety of Rybrevant in combination with chemotherapy as first-line treatment in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. In July, Janssen announced the PAPILLON study met its primary endpoint with a statistically significant and clinically meaningful improvement in PFS (as measured by BICR) in patients receiving Rybrevant plus chemotherapy versus chemotherapy alone. The combination of Rybrevant and chemotherapy demonstrated a safety profile consistent with the safety profiles of the individual components.

Following Breakthrough Therapy Designation from the U.S. FDA in 2020, Rybrevant received accelerated approval in 2021 as the first fully-human, bispecific antibody for the treatment of patients with NSCLC with EGFR exon 20 insertion mutations. The sBLA submission for Rybrevant is also intended to satisfy the regulatory requirements of the accelerated approval confirming the clinical benefit observed in the Phase I CHRYSALIS study.