Puma Biotechnology Inc. said the U.S. Food and Drug Administration granted an orphan drug status to its drug Nerlynx for treating certain breast cancer patients.
Nerlynx, or neratinib, was awarded the designation to treat patients with breast cancer whose disease has spread to the brain.
Nerlynx is approved in the U.S. and Europe as an add-on therapy for patients who have early-stage HER2-positive breast cancer and have already been treated with Roche Holding AG's oncology drug Herceptin.
The drug was also recommended by the U.K. National Institute for Health and Care Excellence for patients with breast cancer who have undergone surgery to reduce the risk of their disease returning.
The U.S. regulator awards orphan drug designations to medicines that treat diseases that affect fewer than 200,000 people in the country. The designation qualifies sponsors for several key benefits and incentives, including opportunities for grant funding towards clinical trial costs, tax credits, user fee waivers and the potential for a seven-year period of marketing exclusivity upon approval.
