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.
Renew Biotechnologies names new chief operating officer
Teva, Sanofi accelerate inflammatory bowel disease drug trial
Ro adds David B Allison to Advisory Board
Charles River Laboratories and Autobahn Labs forge alliance to boost academic drug discovery
Nkarta partnering with Columbia on investigator-led lupus trial for NKX019
Gilead's lenacapavir demonstrates 100% efficacy in HIV prevention trial
Anixa Biosciences' ovarian cancer CAR-T therapy individual patient IND receives FDA approval
Evergreen Nephrology names new director
Emmaus Life Sciences names new chief executive officer
FDA feedback boosts Diamyd Medical's pathway to accelerated approval for Type 1 Diabetes Therapy
TC BioPharm (Holdings) doses sixth patient in TCB-008 clinical trial
Caidya names new chief executive officer
Ionis Pharmaceuticals reports positive results for ION582 in Angelman syndrome study
Nuvalent launches HEROEX-1 trial for HER2-selective inhibitor NVL-330
Astellas and Osaka University collaborate on stem cell therapy for disc degeneration