This article is more than 5 years old. Information may no longer be current.

FDA grants priority review to Cabometyx for advanced renal cell carcinoma

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA granted priority review to cabozantinib for first-line treatment of advanced renal cell carcinoma, according to the drug’s manufacturer.

A supplemental new drug application included data from the randomized, open-label, active-controlled phase 2 CABOSUN trial.

CABOSUN included 157 patients with poor- or intermediate-risk clear-cell metastatic renal cell carcinoma.

Researchers randomly assigned 79 patients to receive initial targeted therapy with 60 mg once-daily cabozantinib (Cabometyx, Exelixis), a small molecule inhibitor of the MET, AXL and VEGFR2 tyrosine kinases. The other 78 patients received 50 mg daily sunitinib (Sutent, Pfizer) — a current standard of care — administered on a 4-weeks-on, 2-weeks-off schedule.

PFS served as the primary endpoint. Secondary endpoints included OS and objective response rate.

As HemOnc Today has previously reported, researchers observed a statistically significant PFS benefit among cabozantinib-treated patients (median, 8.6 months vs. 5.3 months; HR = 0.48; 95% CI, 0.31-0.74).

“The acceptance of the supplemental new drug application filing with a priority review is an important regulatory milestone for Cabometyx and for our mission to improve treatment outcomes for patients with cancer,” Gisela Schwab, MD, president of product development and medical affairs and chief medical officer at Exelixis, said in a company-issued press release. “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 renal cell carcinoma who are in need of new treatment options.”

The FDA set an action date for Feb. 15.