FDA Grants Priority Review for Cabozantinib in Previously Untreated Advanced Renal Cell Carcinoma

On October 16, the U.S. Food and Drug Administration (FDA) determined the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The FDA granted Priority Review of the filing, and assigned a Prescription Drug User Fee Act action date of February 15, 2018.

“The acceptance of the sNDA filing with a Priority Review is an important regulatory milestone for cabozantinib and for our mission to improve treatment outcomes for patients with cancer,” said Gisela Schwab, MD, President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We look forward to working with the FDA as they review the application in our effort to offer cabozantinib to patients with previously untreated metastatic RCC who are in need of new treatment options.”

The sNDA is based on data from CABOSUN, a randomized phase II trial conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP).

Cabozantinib was previously approved by the FDA on April 25, 2016, for the treatment of patients with advanced RCC who have received prior antiangiogenic therapy. The approval was based on results from the phase III METEOR trial, which demonstrated that cabozantinib provided a statistically significant and clinically meaningful improvement in overall survival, progression-free survival, and objective response rate as compared with everolimus in this patient population.

About the CABOSUN Study

On May 23, 2016, Exelixis announced that CABOSUN met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared with sunitinib in patients with advanced intermediate- or poor-risk RCC as determined by investigator assessment. These results were first presented by Toni Choueiri, MD, at the European Society for Medical Oncology (ESMO) 2016 Congress, and published in the Journal of Clinical Oncology. In June 2017, a blinded independent radiology review committee (IRC) confirmed that cabozantinib provided a clinically meaningful and statistically significant improvement in the primary efficacy endpoint of investigator-assessed progression-free survival. Results from the IRC review were presented by Dr. Choueiri at the ESMO 2017 Congress.

CABOSUN was a randomized, open-label, active-controlled phase II trial that enrolled 157 patients with advanced RCC determined to be intermediate- or poor-risk by the IMDC criteria. Patients were randomized 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, 4 weeks on followed by 2 weeks off). The primary endpoint was progression-free survival. Secondary endpoints included overall survival and objective response rate. Eligible patients were required to have locally advanced or metastatic clear-cell RCC, ECOG performance status 0–2, and had to be intermediate or poor risk per the IMDC criteria (Heng et al, JCO, 2009). Prior systemic treatment for RCC was not permitted.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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