The FDA granted Agenus fast track designation to investigate balstilimab monotherapy as well as balstilimab and zalifrelimab as a combination therapy for the treatment of advanced cervical cancer, according to a recent Agenus press release.1
Agenus, an immune-oncology organization with a number of agents that activate immune responses to cancers, also expects to file 2 biologic licensing applications this year for the balstilimab and zalifrelimab combination, as well as balstilimab monotherapy as treatment for metastatic cervical cancer.
“We are pleased to have now been granted Fast Track designation by FDA for both balstilimab as a monotherapy and in combination with zalifrelimab (anti-CTLA-4) in recognition of the high unmet medical need in second line cervical cancer,” Dr. Anna Wijatyk, head of clinical development at Agenus, said in a press release. “The Fast Track designation…
