The U.S. Food and Drug Administration (FDA) has now given fast track status to Agenus’ balstilimab — both alone and in combination — as an immunotherapy candidate for advanced metastatic cervical cancer. This designation, given separately to these different treatment approaches, is meant to help speed its development by facilitating discussions with the FDA and enabling the therapy to qualify for priority review and accelerated approval, provided certain criteria are met. The company plans to file two biologics license applications (BLAs) seeking approval of balstilimab alone and in combination with zalifrelimab as a second-line treatment of advanced cervical cancer that responded poorly to platinum chemotherapy. “We are pleased to have now been granted Fast Track designation by FDA for both balstilimab as a monotherapy and in combination…
April 15, 2020April 15, 2020