US action on subcutaneous cancer drugs

Friday's US approval of a subcutaneous formulation of Keytruda marks the third for an anti-PD-(L)1 antibody, but just as interesting is what the FDA will do about SC forms of several other oncology drugs. Johnson & Johnson/Genmab's Darzalex Faspro, for instance, is awaiting regulatory action in high-risk smouldering myeloma, as is a SC formulation of J&J's Rybrevant. The former is likely to be a shoo-in, given a 6-2 adcom vote in its favour, but the filing of the latter already has a CRL under its belt, owing to manufacturing problems. The precise timings for approval remain unclear, but SC delivery is known to be one strategy for optimising Rybrevant's dosing regimen. Equally intriguing is a filing for a SC form of Roche's Lunsumio in follicular lymphoma; this has just been recommended for EU approval, but in the US it had a September PDUFA date before quietly being delayed by three months. As for SC Keytruda, that drug is now available as Keytruda Qlex for all solid tumour indications of the IV version; on the same day the CHMP recommended a similar EU nod, though here prior convention is being followed, with the trade name being simply "Keytruda SC".

SC formulations of selected cancer drugs

Source: OncologyPipeline.