Research & Development
Genelux secures FDA Fast Track designation for Olvi-Vec in ovarian cancer
27 November 2023 -

Late clinical-stage immuno-oncology company Genelux Corporation (NASDAQ:GNLX) revealed on Monday that it has been granted Fast Track designation by the US Food and Drug Administration (FDA) for Olvi-Vec (olvimulogene nanivacirepvec).

This designation relates to 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 enrol our Phase 3 OnPrime study," commented Thomas Zindrick, president, vhairman and CEO of Genelux.

The ongoing Phase 3 trial is evaluating the efficacy and safety of Olvi-Vec in combination with platinum-based chemotherapy in patients with platinum-resistant/refractory ovarian cancer.

Fast Track designation expedites the drug development and review process for treatments targeting serious and life-threatening conditions. It includes regular engagements with the FDA review team and the possibility of eligibility for Priority Review and Rolling Review if specific criteria are met.