Navicixizumab Earns FDA Fast Track Designation for Heavily Pretreated Ovarian Cancer

Navicixizumab Earns FDA Fast Track Designation for Heavily Pretreated Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has granted fast track designation to navicixizumab (OMP-305B83) as a potential therapy for heavily pretreated ovarian cancer, Mereo BioPharma, the therapy’s developer, announced. Fast track designation is given to investigational compounds that show considerable potential in treating serious conditions for which available treatments still fall short. This designation is meant to expedite clinical development, review process, and entry into the market (if it shows positive results in clinical trials). “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,” Jill Henrich, senior vice president of regulatory affairs at Mereo BioPharma, said in a press release. Navicixizumab is a bispecific antibody that targets both Delta-like ligand 4 (DLL4) — involved in the development of cancer stem cells and formation of new blood vessels, critical for tumor growth — and vascular endothelial growth factor (VEGF) — essential for the formation of new blood vessels. Preclinical studies in mice
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