Janssen gains conditional EU marketing authorization for Rybrevant

US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Janssen subsidiary has received Conditional Marketing Authorization (CMA) approval from the European Commission for Rybrevant (amivantamab) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy.

Amivantamab is the first approved treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for NSCLC. The drug was approved by the US Food and Drug Administration in May this year.

Rybrevant is the product of a 2012 licensing agreement in which J&J contracted with Denmark-based Genmab (OMX: GEN) to make use of its DuoBody technology platform. The Danish firm became eligible for milestone and license payments of up to $175 million.