Shares of Exelixis (EXEL) jumped in early trading after the biopharmaceutical company said it received priority review from the U.S. Food and Drug Administration for a treatment for advanced renal cell carcinoma. Separately, the company said a global Phase 3 trial met its primary endpoint of overall survival.

FDA PRIORITY REVIEW: Exelixis announced this morning that it has won priority review status from the FDA for its supplemental new drug application for a treatment for advanced renal cell carcinoma. The biotech company said its sNDA is based on results of data from Cabosun, a phase 2 trial of Cabometyx geared towards patients with previously untreated advanced renal cell carcinoma, or RCC. The Phase 2 trial was conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program. Cabometyx was approved by the FDA in April 2016 for the treatment of patients with advanced RCC who have received prior anti-angioegenic therapy. According to Exelixis, the American Cancer Society’s 2017 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S. Exelixis said today that the FDA assigned a Prescription Drug User Fee Act, or PDUFA, action date of February 15, 2018.

CABOMETYX MEETS ENDPOINT: Separately, Exelixis announced this morning that Cabometyx met the primary goal of overall survival in a global Phase 3 Celestial trial with partner Ipsen (IPSEY). The companies said that Cabometyx showed statistically significant and “clinically meaningful improvement” in overall survival compared to placebo in patients with advanced hepatocellular carcinoma. Based on these results, Exelixis said it plans to submit a supplemental new drug application to the FDA in the first quarter of 2018. “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 at Exelixis.