FDA Places PC14586, for Cancers with Mutant Protein, on Fast Track

FDA Places PC14586, for Cancers with Mutant Protein, on Fast Track
The U.S. Food and Drug Administration (FDA) has granted fast track designation to PC14586 as a potential treatment of advanced cancers that harbor a specific mutation affecting the protein p53, which includes some ovarian cancers. Fast track is given to support therapies with the potential to fill a serious unmet medical need. They are eligible for benefits that include more frequent discussions with the FDA, and can be considered for accelerated approval and priority review. “While targeted therapies have improved outcomes for many patients with advanced cancers, those with tumors carrying a p53 mutation do not yet have precision treatment options for these mutations and often have poor outcomes," David Mack, PhD, president and CEO of PMV Pharma, which is developing the therapy, said in a press release. "We look forward to working closely with the FDA as we advance PC14586 through the clinic as part of our mission to discover and develop novel, tumor-agnostic, precision oncology therapies,” added Mack. PC14586 is designed to target a mutated form o
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