On October 1, 2018 Corcept Therapeutics Incorporated (NASDAQ: CORT), a company engaged in the discovery, development and commercialization of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported that the Food and Drug Administration (FDA) has granted orphan drug status to Corcept’s selective cortisol modulator relacorilant to treat patients with pancreatic cancer (Press release, Corcept Therapeutics, OCT 1, 2018, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-receives-orphan-designation-relacorilant [SID1234530684]). Corcept is conducting clinical trials of relacorilant in combination with nab-paclitaxel (Celgene Corporation’s drug, Abraxane) as a treatment for pancreatic cancer and other solid tumors.
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Orphan drug designation is granted by the FDA to encourage the development of treatments for diseases that affect fewer than 200,000 patients in the United States. Drugs that receive orphan status obtain seven years of marketing exclusivity from the date of drug approval, tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process. Receiving orphan drug designation does not alter the standard regulatory requirements and process for obtaining marketing approval.
"We are pleased the FDA has granted relacorilant orphan drug status for the treatment of pancreatic cancer. Pancreatic cancer has a poor prognosis and patients have few treatment options," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer. "The data we have generated so far in this indication have been very encouraging. Five of nine patients who received the minimum therapeutic dose in our Phase 1/2 trial of relacorilant plus nab-paclitaxel demonstrated durable disease control. By year-end we expect to have learned enough to determine a potential path toward a pivotal study in this indication."
About Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer-associated mortality, with a five-year survival rate of five percent. In the United States, an estimated 33,000 patients are diagnosed with the disease each year.