Exelixis Inc. (NASDAQ: EXEL) shares surged over 25 percent on Monday after its announcement that the U.S. Food and Drug Administration (FDA) has approved and granted the company’s new drug for for kidney cancer for priority review.
The company also announced its global phase 3 CELESTIAL trial met all its primary endpoints of overall survival in the phase 3 clinical trial. Exelixis drug, CABOMETYX (cabozantinib), showed significant and clinical improvement in the media overall survival compared to the placebo to treat patients with advanced hepatocellular carcinoma (HCC).
Hepatocellular carcinoma is the most common form of kidney cancer causing pain in the abdomen area. Symptoms aren’t present in the early stages, but by the late stages, symptoms can include weight loss, upper abdominal pain, or yellowing of the skin (jaundice). It made up three-fourths of the nearly 41,000 cases that will be diagnosed in 2017 in the U.S.
“We are excited that these positive results from the phase 3 CELESTIAL trial bring us one step closer to the potential of offering previously treated patients with this aggressive form of advanced liver cancer a much-needed new treatment option,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis.
After the successful clinical trial, the drug is now moved up to priority review by the FDA.
“We look forward to working with the FDA as they review the application in our effort to offer CABOMETYX to patients with previously untreated metastatic RCC who are in need of new treatment options,” said Schwab.
CABOMETYX was previously approved by the FDA on April 2016.
The FDA granted Priority Review of the filing and assigned a Prescription Drug User Fee Act (PDUFA) action date for February 2018.