FDA grants Relacorilant the qualification for orphan drugs for pancreatic cancer
Pancreatic cancer is the fourth leading cause of cancer-related deaths with a 5-year survival rate of 5%. In the United States, an estimated 33,000 people are diagnosed with this disease each year.
Recently, the US Food and Drug Administration (FDA) granted Corcept Therapeutics Incorporated a selective cortisol regulator, reclacorilant, for the treatment of orphan drugs in patients with pancreatic cancer. Corcept is conducting a clinical trial of relacorilant combined with nab-paclitaxel (Celgene drug Abraxane®) for the treatment of pancreatic cancer and other solid tumors.
The FDA grants orphan drug qualifications to encourage the development of treatments for diseases in the United States with fewer than 200,000 patients. The orphan drug qualification determination will not change the standard regulatory requirements and procedures required for drug approval, but the drug that obtained the certification will enjoy the tax credit for clinical trial costs, the exemption from the listing application fee, and the FDA's assistance. After approval, it will have 7 years of market exclusive rights.
“We are pleased that the FDA has granted relacorilant the orphan drug qualification for pancreatic cancer. The prognosis of pancreatic cancer is poor and there are few treatment options for patients,” said Dr. Joseph K. Belanoff, CEO of Corcept, “The treatment of this indication has been produced so far. The data is very encouraging. Five of the nine patients who participated in our relacorilant combined with the nab-paclitaxel 1/2 trial and received the lowest dose of treatment showed persistent disease control. By the end of the year, we expect to receive enough The data to determine the potential path for conducting key research."