Janssen seeks new Rybrevant indication

Johnson & Johnson’s (NYSE: JNJ) Janssen subsidiary has submitted a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for Rybrevant (amivantamab).

The submission, supported by data from the Phase III PAPILLON study, seeks approval of amivantamab in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Rybrevant was previously granted a conditional marketing authorization by the European Commission in December 2021 as the first fully-human, bispecific antibody for the monotherapy treatment of patients with NSCLC with EGFR exon 20 insertion mutations, after failure of platinum-based therapy.