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The FDA has granted Fast Track designation to balstilimab, an investigational anti-PD-1 agent for the treatment of patients with cervical cancer, based on comprehensive data that suggest balstilimab can fill an unmet medical need in the space, Agenus, Inc announced in a press release. In light of the new designation, the company now plans to submit 2 Biologic License Applications in 2020, for this indication and the other for the combination of balstilimab and zalifrelimab in metastatic cervical cancer.

The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.