Written by Modality Solutions
Posted on: July 26, 2021
LEXINGTON, Mass., June 17, 2021 (GLOBE NEWSWIRE) — Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, today announced that the U.S. Food and Drug Administration (FDA) has 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 drugs which, if approved, may provide 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. (source: Agenus press release)
Modality Solutions works with biopharma innovators like Agenus to ensure their cold chains are ready for regulatory filing success. The majority of our clients are working under FDA Expedited Review Program pathways, including Priority Review, Fast Track Designation, Breakthrough Designation, and Accelerated Approval.