BioAtla gains FDA Fast Track Designation for ozuriftamab vedotin
Betsy Goodfellow | July 25, 2024 | News story | Medical Communications | BioAtla, FDA, Oncology, fast track designation, ozuriftamab vedotin
BioAtla has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ozuriftamab vedotin, a conditionally and reversibly active ROR2 antibody drug conjugate (ADC).
The drug is indicated for the treatment of patients with recurrent or metastatic 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.
This designation follows promising clinical activity observed in its phase 2 clinical trial, which also demonstrated a manageable safety profile for the drug.
The company is expected to meet with the FDA for guidance on a potential registration trial during the second half of 2024.
Jay M Short PhD, chairman, chief executive officer and president at BioAtla, commented: “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. To date, ozuriftamab vedotin has shown promising clinical activity in treatment-refractory SCCHN patients who had a median of three 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.”
Betsy Goodfellow
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