Merus N.V. announced on February 18, 2025, that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) to petosemtamab. This designation is for petosemtamab in combination with pembrolizumab for the first-line treatment of adult patients with recurrent or metastatic programmed death-ligand 1 (PD-L1) positive head and neck squamous cell carcinoma (r/m HNSCC) with a combined positive score (CPS) ≥ 1.
This marks the second BTD for petosemtamab, following an initial BTD for monotherapy in 2L+ r/m HNSCC. The designation is supported by updated data from an ongoing Phase 1/2 trial, which previously demonstrated a 67% response rate among 24 evaluable patients in 1L HNSCC with pembrolizumab.
The BTD is intended to expedite the development and review of medicines for serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies. This designation allows for more intensive FDA guidance, organizational commitment, and eligibility for rolling and priority review, accelerating petosemtamab's path to a potential Biologics License Application (BLA) submission.
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