Ficerafusp Alfa Granted Breakthrough Therapy Designation by US FDA for 1L HPV-Negative R/M HNSCC
“BTD provides external validation of the importance of ficerafusp alfa’s best-in-disease potential, and solidifies the foundation for our ongoing pivotal trial, FORTIFI-HN01,” said Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics. “We look forward to working closely with the FDA to bring this therapy to patients as quickly as possible.”
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