The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
The European Commission granted conditional marketing authorization for Libtayo (cemiplimab) for treating adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
Sanofi SA’s skin cancer drug Libtayo, made in partnership with Regeneron Pharmaceuticals Inc., was approved by the U.S. Food and Drug Administration.
The European Medicines Agency (EMA) will review the Dupixent (dupilumab) and cemiplimab products being developed by drugmakers Sanofi and Regeneron, the companies said.
Impressive top-line results were reported from a pivotal Phase II study for the PD-1 inhibitor cemiplimab.