CHMP recommends, FDA approves subQ Keytruda

EMA’s CHMP recommended two subcutaneous formulations of approved cancer antibodies at its September meeting: Keytruda pembrolizumab solution for injection and Lunsumio mosunetuzumab solution for injection.

FDA approved the new Keytruda formulation on Friday as Keytruda Qlex pembrolizumab/ berahyaluronidase alfa-pmph. The difference in nomenclature reflects a difference in regulation between the two territories; EMA considers the new formulation a variation on the existing MAA, while FDA considers the addition of hyaluronidase to enable subcutaneous injection to create a new combination product, requiring a new BLA. As a new product, Keytruda Qlex restarts the timeline to potential Medicare price negotiation. ...