Genelux Corporation (GNLX), on Tuesday announced that it has aligned with the U.S. Food and Drug Administration or FDA on the approval pathway for its oncolytic virus therapy, Olvi-Vec, in the treatment of platinum-resistant/refractory ovarian cancer or PRROC.
This alignment follows a Type D meeting with the FDA to discuss the ongoing OnPrime/GOG-3076 Phase 3 trial.
At the meeting, the FDA confirmed that data from the OnPrime/GOG-3076 trial could potentially support traditional approval if a clinically meaningful progression-free survival or PFS advantage is shown, with no significant decrease in overall survival or OS.
The FDA also recommended that Genelux request a pre-BLA meeting following the study's completion to discuss topline data.
Olvi-Vec is currently being evaluated in the OnPrime/GOG-3076 trial, a multi-center study aimed at providing a treatment option for ovarian cancer patients with urgent unmet needs.
Genelux is advancing Olvi-Vec with the goal of improving outcomes for patients with this difficult-to-treat disease.
GNLX is trading at $3.11 down by 19.51 percent on the Nasdaq.
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