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Bicara Therapeutics Announces Ficerafusp Alfa Granted Breakthrough Therapy Designation by U.S. FDA for 1L HPV-Negative R/M HNSCC
Designation supported by results from multiple dose cohorts from the Phase 1/1b trial of ficerafusp alfa in 1L HPV-negative R/M HNSCCBOSTON, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination
About this update from Bicara Therapeutics Inc.
[{"type":"image","alt":"Bicara Therapeutics Inc.","displaySize":"","headline":null,"caption":"Bicara Therapeutics Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":86,"url":"https://media.zenfs.com/en/globenewswire.com/6ccfcafb8abd88270fbc9bc7dafef0fe"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/N7aaUVu45bXz.VUeCxgrhA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEyMDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/6ccfcafb8abd88270fbc9bc7dafef0fe","width":300,"height":86}},"lazy":false},{"type":"text","content":"Designation supported by results from multiple dose cohorts from the Phase 1/1b trial of ficerafusp alfa in 1L HPV-negative R/M HNSCC","length":133,"tagName":"p"},{"type":"text","content":"BOSTON, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today 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 (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma.","length":702,"tagName":"p"},{"type":"text","content":"This designation from the FDA underscores the growing recognition of HPV-negative HNSCC as a distinct clinical indication within head and neck cancer – one with particularly poor outcomes, limited therapeutic options, and that represents the vast majority of patients.","length":268,"tagName":"p"},{"type":"text","content":"“This recognition highlights the urgent unmet need for patients with HPV-negative R/M HNSCC,” said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. “It also reinforces our conviction that depth and durability of response, driven by ficerafusp alfa's ability to synergize with pembrolizumab and enable tumor penetration, are key to achieving long-term clinical benefit.”","length":387,"tagName":"p"},{"type":"text","content":"BTD was supported by results from multiple Phase 1/1b dose cohorts evaluating ficerafusp alfa in combination with pemb...