Investing.com - Merck & Co (NYSE:MRK) received orphan drug designation from the Food and Drug Administration for pembrolizumab as a treatment for neuroendocrine prostate cancer, the agency announced today.
The FDA granted the designation to pembrolizumab, marketed as Keytruda, on June 6. Orphan drug status provides pharmaceutical companies with incentives to develop treatments for rare diseases affecting fewer than 200,000 people in the United States.
Drugs that receive orphan designation are entitled to seven years of market exclusivity if the FDA approves them for the rare disease indication. Pembrolizumab has not yet received FDA approval for the neuroendocrine prostate cancer indication.
Merck is currently investigating pembrolizumab in clinical trials for neuroendocrine prostate cancer, typically for heavily pre-treated or metastatic cases.
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