Janssen files for EMA approval of Rybrevant

US healthcare giant Johnosn & Johnson (NYSE: JNJ) subsidiary Janssen says it has submitted a type II extension of indication application to the European Medicines Agency (EMA) seeking approval of Rybrevant (amivantamab).

The filing seeks approval for Rybrevant in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations, after failure of prior therapy including a third-generation EGFR tyrosine kinase inhibitor (TKI).

“Patients with EGFR-mutated advanced non-small-cell lung cancer treated with osimertinib [AstraZeneca’s blockbuster drug Tagrisso] inevitably develop resistance mechanisms and are faced with poor outcomes on platinum-based chemotherapy alone,” said Catherine Taylor, vice president, EMEA medical affairs, therapy area strategy, at Janssen-Cilag.