Economy

Exelixis cancer drug meets key goal in late-stage trial

The primary endpoint was overall survival.

According to the release, the FDA determined the company's supplemental New Drug Application (sNDA) for CaboMetyx (cabozantinib) for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review.

French drugmaker Ipsen and its USA partner Exelixis have announced that the CELESTIAL trial met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma (HCC).

Hepatocellular carcinoma is the most common form of kidney cancer causing pain in the abdomen area. It made up three-fourths of the almost 41,000 cases that will be diagnosed in 2017 in the U.S. Interim looks at data often have higher thresholds for success than the final readouts, so there's a good chance that the data will look pretty good, but investors will have to wait for a medical conference where Exelixis will present the data to find out.

Sales in liver cancer could come even earlier since Cabometyx is already on the market as a second-line kidney cancer treatment.

After the successful clinical trial, the drug is now moved up to priority review by the FDA.

The FDA granted Priority Review of the filing and assigned a Prescription Drug User Fee Act (PDUFA) action date for February 2018.



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