Posted by Michael Wonder on 13 Mar 2020
Agenus receives fast track designation for balstilimab & zalifrelimab in advanced cervical cancer
12 March 2020 - Agenus today announced that the U.S. FDA has granted Agenus fast track designation for investigation of balstilimab in combination with zalifrelimab for the treatment of patients with relapsed or refractory metastatic cervical cancer.
This designation was based on comprehensive data that support the potential for balstilimab and zalifrelimab to address a significant unmet medical need.
Agenus expects to file 2 BLAs this year for accelerated approval of the combination of balstilimab and zalifrelimab and balstilimab monotherapy in metastatic cervical cancer.
