BRIEF—Janssen files sBLA to extend indication for Rybrevant

US healthcare giant Johnson & Johnson’s subsidiary Janssen Pharmaceuticals has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for the expanded approval of Rybrevant (amivantamab-vmjw).

Janssen is seeking authorization for Rybrevant in combination with chemotherapy (carboplatin-pemetrexed) for the 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 sBLA is being reviewed by the FDA through the Real-Time Oncology Review (RTOR) program.

Following Breakthrough designation from the FDA in 2020, the agency granted accelerated approval for Rybrevant 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.