FDA grants fast track designation to DKN-01 for two gastrointestinal cancers
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The FDA granted fast track designation to DKN-01 for the treatment of certain patients with gastric cancer or gastroesophageal junction adenocarcinoma, according to the agent’s manufacturer.
The designation applies to use of DKN-01 (Leap Therapeutics) by patients whose tumors express high Dickkopf-1 protein (DKK1) and whose disease progressed during or after fluoropyrimidine- and platinum-containing chemotherapy and — if appropriate — HER-2 targeted therapy.
DKN-01 is a humanized monoclonal antibody that binds to and blocks activity of the DKK1 protein, a modulator of Wnt/Beta-catenin signaling.
Clinical trials are underway to evaluate the agent as treatment for gastroesophageal, gynecologic, prostate and hepatobiliary cancers.
“The [fast track] designation highlights the existing unmet medical need for new and effective treatments for this patient population,” Douglas E. Onsi, president and CEO of Leap Therapeutics, said in a company-issued press release. “We believe that DKN-01 shows promise as a novel treatment option for biomarker-selected patients with these cancers, and this designation provides us with earlier and more frequent opportunities to interact with the FDA during the development of DKN-01.”
As Healio previously reported, the FDA also granted orphan drug designation to DKN-01 for treatment of gastric cancer and gastroesophageal junction adenocarcinoma.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
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