Johnson & Johnson (J&J; NYSE: JNJ) has announced that Rybrevant (amivantamab) has received its first market approval in Canada. The drug is approved as a first-line treatment in combination with chemotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.
Rybrevant, co-discovered by J&J’s subsidiary Janssen R&D and Danish biotech Genmab A/S, is a fully-human EGFR-MET bispecific antibody. It targets tumors with activating and resistance EGFR mutations and MET mutations and amplifications, and leverages the immune system for therapeutic effect. J&J secured the first global approval for this molecule in the U.S. in March 2024 for the same indication now approved in Canada. The approval was based on data from the Phase 3, randomized, open-label, multicenter PAPILLON study, which demonstrated a statistically significant increase in progression-free survival (PFS) and a 60% reduction in the risk of death associated with Rybrevant treatment.- Flcube.com
