Posted by Michael Wonder on 19 Apr 2021
Agenus submits balstilimab biologics license application to the U.S. FDA for patients with recurrent or metastatic cervical cancer
19 April 2021 - Submission has been made for review under the accelerated approval pathway
Agenus today announced the submission of a Biologics License Application (BLA) to the U.S. FDA.
The BLA has been submitted for the accelerated approval of balstilimab, Agenus’ anti-PD-1 antibody, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and includes data from its pivotal Phase 2 single-arm clinical trial, presented at the European Society for Medical Oncology Virtual Congress 2020.
