Petosemtamab granted 2nd Breakthrough Therapy designation by FDA
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to Dutch clinical-stage drug developer Merus (Nasdaq: MRUS), for its 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 combined positive score (CPS) ≥ 1.
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