In 2019, the American Cancer Society estimates that about 22,530 women will receive a new diagnosis of ovarian cancer and that about 13,980 women will die from this disease in the United States alone. Ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. A woman’s risk of getting ovarian cancer during her lifetime is about one in 78.
Now, Mereo BioPharma Group PLC (NASDAQ: MREO) is taking steps toward a solution to ovarian cancer with its most recent update from the U.S. Food and Drug Administration (FDA).
The FDA granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal or fallopian tube cancer in patients who have received at least three prior therapies and/or prior bevacizumab.
Navicixizumab has completed a Phase 1a monotherapy study in patients with various types of refractory solid tumors and is currently being evaluated in an ongoing Phase 1b study in combination with paclitaxel in patients with advanced heavily pretreated ovarian cancer.
Jill Henrich, Senior Vice President of Regulatory Affairs at Mereo BioPharma, said:
We are pleased that the FDA continues to recognize the potential of navicixizumab to become a viable new treatment option for patients with platinum-resistant ovarian cancer who failed multiple other therapies. This designation follows our successful Type B End of Phase 1 meeting with the FDA held in July 2019 regarding a potential pathway for accelerated approval for navicixizumab where the FDA agreed in principle on an outline for a Phase 2 clinical trial that could potentially support accelerated approval of navicixizumab in patients with ovarian cancer who have become resistant to prior therapies.
Shares of Mereo traded down about 1% Monday morning to $3.11, in a 52-week range of $2.18 to $8.48.