Mereo navicixizumab gets FDA fast track designation for ovarian cancer

Mereo BioPharma’s (NASDAQ:MREO) navicixizumab received FDA fast track designation 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 is a bispecific antibody designed to induce potent anti-tumor responses. The drug is currently being evaluated in an ongoing Phase 1b study in combination with paclitaxel in patients with advanced, heavily pretreated ovarian cancer.

“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,” Jill Henrich, SVP of regulatory affairs, said in a statement.

“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,” she added.


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