Bicara Therapeutics (BCAX) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, to ficerafusp alfa in combination with pembrolizumab for the first line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma, HNSCC, whose tumors express programmed death-ligand 1 with combined positive score greater than or equal to1, excluding human papillomavirus-positive oropharyngeal squamous cell carcinoma.
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