EC approves J&J’s subcutaneous Rybrevant

Following hot on the heels of Monday’s European Commission EC approval of an indication extension for Johnson & Johnson’s (NYSE: JNJ) Darzalex (daratumumab) for the treatment of adult patients with newly diagnosed multiple myeloma, comes a second EC approval today – this time in lung cancer.

J&J subsidiary Janssen-Cilag announced that the European Commission has approved an extension of marketing authorization for a subcutaneous (SC) formulation of Rybrevant (amivantamab), in combination with Lazcluze (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.

For these indications, it is recommended that SC amivantamab is administered weekly from Weeks 1 to 4 (total of four doses), then every two weeks starting at Week 5 onwards.