Exelixis submits sNDA for CABOMETYX
Exelixis (EXEL) announced it has completed the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for CABOMETYX tablets as a treatment for patients with previously untreated advanced renal cell carcinoma.
The sNDA submission is based on results from the CABOSUN randomized phase 2 trial of CABOMETYX in patients with previously untreated advanced RCC with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium.
CABOSUN 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.
On May 23, 2016, Exelixis announced that CABOSUN met its primary endpoint, demonstrating a clinically meaningful and statistically significant improvement in progression-free survival compared with sunitinib in patients with advanced intermediate- or poor-risk RCC as determined by investigator assessment.
In June 2017, Exelixis announced that the analysis of the review by a blinded independent radiology review committee confirmed the primary efficacy endpoint results of investigator-assessed PFS from the CABOSUN trial.
CABOMETYX was previously approved by the FDA on April 25, 2016 for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy.
The approval was based on results from the phase 3 METEOR trial, which demonstrated that CABOMETYX provided a statistically significant and clinically meaningful improvement in overall survival, PFS and objective response rate as compared with everolimus in this patient population.
Bristol-Myers Squibb (BMY) reported “mixed” top-line Phase III CheckMate-214 data on 1,070 front-line metastatic renal cell carcinoma patients, Piper Jaffray analyst Edward #Tenthoff tells investors in a research note.
He continues to expect a front-line renal cell carcinoma supplemental new drug application for Exelixis’ (EXEL) Cabometyx in Q3 with approval next year.
Tenthoff anticipates Cabometyx use in front-line RCC expanding the current market opportunity before ultimately showing IO combination benefit. The analyst reiterates an Overweight rating on Exelixis shares with a $29 price target.
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