FDA Agrees to Speed Up Review of Ofra-Vec for Platinum-Resistant Ovarian Cancer


The FDA granted a Fast Track designation to ofra-vec plus paclitaxel for the treatment of patients with platinum-resistant ovarian cancer.

The Food and Drug Administration (FDA) granted a fast track designation to ofra-vec (ofranergene obadenovec or VB-111) plus paclitaxel for the treatment of patients with platinum-resistant ovarian cancer. In doing so, the agency agreed to speed up the development and review of the drug combination, with the potential for getting it to patients, as the therapy fills an unmet medical need.

“We are pleased to receive FDA fast track designation for ofra-vec in platinum-resistant ovarian cancer. The fast track designation can facilitate the process towards potential registration and, importantly, may help expedite the time to market for ofra-vec, if approved,” said Dr. Dror Harats, chief executive officer of VBL Therapeutics, the manufacturer of ofra-vec, in a press release.

Ofra-vec, which is being studied in multiple types of solid tumors, is an investigational, anti-cancer gene therapy that uses an anti-tumor response to block tumor vasculature (blood vessels), causing them to die. It is administered intravenously every six to eight weeks, and previous studies have shown that it is generally well-tolerated.

The fast track designation was granted based on the phase 3, international, randomized OVAL trial, which is comparing ofra-vec plus paclitaxel to placebo plus paclitaxel in patients with recurrent ovarian cancer that was resistant to platinum-based therapies.

The OVAL study had two main goals: improve average progression-free survival (known as the time from treatment until disease gets worse) and overall survival (the time from treatment until death from any cause) in the experimental group. According to the press release, meeting either of these endpoints could support a biologics license application from the FDA, meaning that the drug combination could be entered into the market.

Early progression-free survival data is expected within the first half of 2022, while overall survival data is expected in 2023.

“The readout of the progression-free survival primary endpoint in the OVAL trial will be an important milestone for VBL in the second half of this year. We believe that, if positive, this will support a biologics license application submission to the FDA,” Harats said.

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