(RTTNews) - Bicara Therapeutics Inc. (BCAX) announced the FDA has granted Breakthrough Therapy Designation 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 whose tumors express programmed death-ligand 1 with combined positive score 1, excluding human papillomavirus-positive oropharyngeal squamous cell carcinoma.
Claire Mazumdar, Chief Executive Officer of Bicara Therapeutics, said: "We look forward to working closely with the FDA to bring this therapy to patients as quickly as possible."
Shares of Bicara are up 15% in pre-market trade on Monday.
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