Merus Says FDA Grants Breakthrough Therapy Designation For Petosemtamab To Treat Head & Neck Cancer

(RTTNews) - Oncology company Merus N.V. (MRUS) announced Monday 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 (PD-1) or anti-programmed death ligand 1 (PD-L1) 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 (anti-PD-1) antibody announced in August 2023.

BTD is supported by data from the ongoing phase 1/2 open-label, multicenter trial evaluating petosemtamab monotherapy in patients with advanced solid tumors, including previously treated (recurrent or metastatic) HNSCC (NCT03526835).

Merus plans to provide updated efficacy, durability and safety data from this cohort in the second half of 2024.

With this BTD, Merus plans to engage in these discussions with the FDA in an expedited manner as we move toward our goal of a potential Biologics License Application (BLA) submission.