Agenus BLA for Balstilimab as Treatment for Cervical Cancer Granted Priority Review by U.S. FDA

Agenus Inc., an immuno-oncology company with an extensive pipeline of agents including checkpoint antibodies, cell therapies, adjuvants, and vaccines that activate immune response to cancers and infections announced that the U.S. FDA accepted Agenus’ Biologics License Application (BLA) for balstilimab, an anti-PD-1 antibody, for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The FDA has granted priority review to this submission, a designation for medical health supplies that provides significant improvements in the safety or effectiveness of the treatment of serious conditions. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 16, 2021.

About Cervical Cancer

Nearly 14,000 women can expect to be diagnosed with invasive cervical cancer in the United States this year and more than 4,000 are expected to die. Cervical cancer remains one of the leading causes of cancer death in women globally, annually killing more than 300,000 women worldwide. Current therapies for recurrent or metastatic cervical cancer are limited to a small subset of patients with limited benefit.

About balstilimab

Balstilimab is, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Balstilimab 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.