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FDA Grants Balstilimab Fast Track Designation for Cervical Cancer

Jason M. Broderick @jasoncology
Published: Tuesday, Apr 07, 2020

The FDA has granted balstilimab a Fast Track Designation for the treatment of patients with cervical cancer, according to Agenus, the manufacturer of the PD-1 inhibitor.1

, is that cervical cancer is a virally induced tumor that should be highly angiogenic. Virus-induced cancers generally make good targets for immunotherapy because viral proteins are strong immune stimulants, Naumann, professor and director of minimally invasive surgery in gynecologic oncology with Levine Cancer Institute, Carolinas Medical Center, Atrium Health, explained to the attendees.


  1. Agenus Receives Fast Track Designation for Balstilimab in Advanced Cervical Cancer. Posted April 7, 2020. Accessed April 7, 2020.
  2. Agenus Receives Fast Track Designation for Balstilimab & Zalifrelimab in Advanced Cervical Cancer. Accessed March 12, 2020. Published March 12, 2020.
  3. Agenus Announces Positive Interim Data from Balstilimab and Zalifrelimab Clinical Trials in Second-Line Cervical Cancer. Published online February 20, 2020. Accessed March 12, 2020.
  4. Chung HC, Ros W, Delord JP, et al. Efficacy and safety of pembrolizumab in previously treated advanced cervical cancer: results from the phase II KEYNOTE-158 study. J Clin Oncol. 2019;37(17):1470-1478. doi: 10.1200/JCO.18.01265

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