Federal regulators have granted βFast-Trackβ status to a drug developed by Tucson-based startup Cancer Prevention Pharmaceuticals Inc. for treatment of a rare genetic disease that usually leads to colon cancer.
The decision by the U.S. Food and Drug Administration potentially allows a streamlined path to market for the companyβs lead drug candidate, CPP-1X, in combination with another drug for treatment of familial adenomatous polyposis, said Jeff Jacob, Cancer Preventionβs chairman and CEO.
The FDA had previously granted the drug combo βorphan drugβ status, which gives drugmakers financial incentive to help drive development of treatments for rare diseases.
The FDAβs Fast Track designation aims to expedite the review of drugs that treat serious conditions and fill unmet medical needs, making them eligible for accelerated approval and priority review if certain criteria are met.
