FDA has granted Fast Track Designation (FTD) to BioAtla’s ozuriftamab vedotin (CAB-ROR2-ADC) for treating recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) patients who progressed on or after platinum-based chemotherapy and anti-PD-1/L1 antibody therapy.
The FDA emphasized the promising clinical activity observed in BioAtla’s phase 2 clinical trial (BA3021-002) for ozuriftamab vedotin, particularly for HNSCC patients who have exhausted other treatment options.
Jay M. Short, Chairman, CEO, and Co-Founder of BioAtla, acknowledged the FDA’s decision for recognizing the potential of CAB-ROR2-ADC, ozuriftamab vedotin.
He highlighted the unmet need in refractory HNSCC and noted the promising results and safety of ozuriftamab vedotin, planning to discuss a trial with the FDA.
The FTD allowed for more frequent communication between the FDA and BioAtla, potentially expediting the development, review, and approval of ozuriftamab vedotin, which offers new hope to HNSCC patients.
Source: BioAtla Granted FDA Fast Track Designation for Ozuriftamab Vedotin (CAB-ROR2-ADC) for Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
https://ir.bioatla.com/news-releases/news-release-details/bioatla-granted-fda-fast-track-designation-ozuriftamab-vedotin
