Janssen Seeks European Approval of Extended Indication for Rybrevant
The Janssen Pharmaceutical Companies of Johnson & Johnson have requested an extension to the indication application of its fully-human, bispecific antibody treatment, Rybrevant (amivantamab). The submission was announced in an Oct. 6, 2023 company press release.
In the Type II extension request, submitted to the European Medicines Agency (EMA), Janssen is seeking approval for its amivantamab therapy to be used in combination with chemotherapy (carboplatin and pemetrexed) as a first-line treatment for adults with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Janssens’ antibody therapy was granted conditional marketing authorization by the European Commission in December 2021 as a monotherapy for adults with NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy has been unsuccessful.
The indication extension application to EMA is supported by the results of a Phase III clinical study (PAPILLON) that has evaluated the efficacy and safety of amivantamab in combination with chemotherapy as a first line treatment for NSCLC patients with EGFR exon 20 insertion mutations. In July 2023, Janssen revealed that the Phase III study met its primary endpoint, demonstrating that the combination of amivantamab with chemotherapy provided a statistically significant and clinically meaningful improvement in progression-free survival for patients when compared with chemotherapy alone.
