Genelux receives FDA Fast Track designation for Olvi-Vec

Genelux announced that the United States Food and Drug Administration, FDA, has granted Fast Track designation for the development program of Olvi-Vec for the treatment of patients with platinum resistant/refractory ovarian cancer. “The Fast Track designation granted for Olvi-Vec underscores its potential to address unmet medical needs in ovarian cancer, a significant recognition as we continue to enroll our Phase 3 OnPrime study,” said Thomas Zindrick, President, Chairman and CEO of Genelux. “We eagerly anticipate ongoing engagement with the FDA as we progress in the development of this promising treatment.” Genelux is currently conducting OnPrime/GOG-3076, a Phase 3 multi-center, randomized, open-label registrational trial evaluating the efficacy and safety of Olvi-Vec in combination with platinum-based chemotherapy in patients with platinum-resistant/refractory ovarian cancer.