Merus granted BTD by the FDA for petosemtamab

Merus N.V. announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for petosemtamab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma, HNSCC, whose disease has progressed following treatment with platinum based chemotherapy and an anti-programmed cell death receptor-1 or anti-programmed death ligand 1 antibody. This designation follows receipt of Fast Track Designation for petosemtamab for the treatment of patients with recurrent or metastatic HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-programmed cell death protein 1 antibody announced in August 2023.