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FDA授予BioAlta的ozuriiftamab vedotin快速通道地位

2024-07-23 23:29

  • BioAlta (NASDAQ:BCAB) said the FDA has granted Fast Track Designation to its antibody drug conjugate ozuriftamab vedotin in the treatment of certain patients with squamous cell carcinoma of the head and neck, or SCCHN.
  • The agency granted the designation 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, according to a statement.
  • BioAtla (BCAB) added it was on track to meet with the agency for guidance on a potentially registrational study in the second half of 2024.

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