BioAtla Says Its Drug Ozuriftamab Vedotin To Treat SCCHN Got Fast Track Designation

(RTTNews) - BioAtla, Inc. (BCAB) Tuesday said that the Food and Drug Administration or FDA has granted fast track designation to ozuriftamab vedotin, the company's drug candidate for the treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based chemotherapy and anti-PD-1/L1 antibody therapy.

Fast Track Designation could lead to actions to expedite development and review of the drug, including opportunities for frequent interactions with the FDA review team and potential priority review if criteria are met.

In the Phase 2 study, ozuriftamab vedotin has shown promising clinical activity with a manageable safety profile in treatment-refractory SCCHN patients.

The company said it is on track to meet with the FDA for guidance on a potentially registrational trial in the second half of 2024.