BioAtla granted FDA FTD for ozuriftamab vedotin

BioAtla 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. “The FDA’s decision is an important recognition of the potential of our CAB-ROR2-ADC, ozuriftamab vedotin. There remains a significant unmet need in refractory head and neck cancer where previous treatments have failed and current outcomes are suboptimal with low response rates,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. “To date, ozuriftamab vedotin has shown promising clinical activity in treatment-refractory SCCHN patients who had a median of 3 prior lines of therapy. In addition, ozuriftamab vedotin continues to have a manageable safety profile with no new safety signals. We look forward to discussing with the FDA plans for a potential registrational trial in the second half of this year.”