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October 18, 2017updated 02 Dec 2021 9:43am

FDA grants priority review for Exelixis’ Cabometyx to treat advanced RCC

The US Food and Drug Administration (FDA) has granted a priority review for the US-based drug discovery company Exelixis’ supplemental new drug application (sNDA) for cabometyx (cabozantinib) to treat patients with previously untreated advanced renal cell carcinoma (RCC).

Cabometyx is the tablet formulation of cabozantinib available in 20mg, 40mg or 60mg doses and its targets include MET, AXL and VEGFR-1, -2 and -3.

Alongside the priority review, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of 15 February 2018.

Exelixis chief medical officer and Product Development and Medical Affairs president Dr Gisela Schwab said: “The acceptance of the sNDA filing with a priority review is an important regulatory milestone for Cabometyx and for our mission to improve treatment outcomes for patients with cancer.

“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.”

“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.”

The current application is based on data obtained from randomised, open-label, active-controlled Phase II Cabosun trial that has been carried out by The Alliance for clinical trials in oncology as part of Exelixis’ partnership with the National Cancer Institute’s cancer therapy evaluation programme (NCI-CTEP).

The trial involved 157 patients with advanced RCC.

On 25 April last year, Exelixis’ medicine was approved by the FDA for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy.


Image: High magnification micrograph of a clear-cell renal-cell carcinoma. Photo: courtesy of Nephron via Wikipedia.

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