BioAtla Granted FDA Fast Track Designation For Ozuriftamab Vedotin For Treatment Of Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck
Ozuriftamab vedotin, the Company's conditionally and reversibly active antibody drug conjugate directed against ROR2, has shown promising clinical activity with a manageable safety profile in treatment-refractory patients with squamous cell carcinoma of the head and neck (SCCHN) in its Phase 2 clinical trial
The Company is on track to meet with the FDA for guidance on a potentially registrational trial in 2H 2024
SAN DIEGO, July 23, 2024 (GLOBE NEWSWIRE) -- BioAtla, Inc. (NASDAQ:BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ozuriftamab vedotin, the Company's conditionally and reversibly active ROR2 antibody drug conjugate directed for the treatment of patients with recurrent or metastatic SCCHN with disease progression on or after platinum-based chemotherapy and anti-PD-1/L1 antibody therapy.