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# Agenus BLA for Cervical Cancer Therapy
- URL: https://www.fdaweb.com/agenus-bla-for-cervical-cancer-therapy/
- Published: 2021-04-19T12:00:00.000Z
- Updated: 2026-09-14T16:55:27.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149139

*Agenus has submitted a BLA seeking accelerated approval for balstilimab, an anti-PD-1 antibody for treating patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The submission includes data from the company’s pivotal Phase 2 single-arm clinical trial,* which demonstrate that balstilimab shows potential differentiation from other anti-PD-1 antibodies, the company says, adding that data show response rates of 20% in PD-L1 positive tumors, 15% in all tumors (PD-L1 positive and negative), and a median duration of response of 15.4 months. A year ago, FDA granted a fast track designation for balstilimab in recurrent or metastatic cervical cancer based on its potential to provide benefit to patients with a serious condition and an unmet medical need, it says.

*Agenus describes* **b**alstilimab as a novel, monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2\. The therapy is currently in clinical trials as monotherapy and in combination with Agenus' anti-CTLA-4, zalifrelimab, in an ongoing Phase 2 study for recurrent/metastatic cervical cancer.