Exelixis, Inc. EXEL announced that it has submitted a supplemental new drug application (sNDA) to the FDA seeking approval for its lead drug, Cabometyx (cabozantinib), in combination with Bristol Myers Squibb’s BMY immune-checkpoint inhibitor Opdivo (nivolumab) for previously untreated renal cell carcinoma (RCC). RCC is the most common type of kidney cancer in adults.

Shares of the company have rallied 22.8% year to date compared with a flat movement by the industry.

Notably, Cabometyx, a tablet formulation of cabozantinib, is already approved in the United States for the treatment of patients with advanced RCC. The drug is also approved for hepatocellular carcinoma (HCC) patients who have been previously treated with Bayer AG’s BAYRY Nexavar (sorafenib) in Europe and the United States.

The sNDA is supported by data from the phase III pivotal CheckMate-9ER study, which evaluated Cabometyx   plus Opdivo versus Pfizer’s PFE Sutent (sunitinib) in previously untreated patients with advanced or metastatic disease. The study met theprimary endpoint by showing that treatment with Cabometyx+ Opdivo results insignificant improvement in progression-free survival (PFS) compared with Sutent. Two secondary endpoints of overall survival and the objective response ratewere also achieved.

If approved, the combination of Cabometyx and Opdivo will be an important, new first-line treatment regimen for RCC patients who need additional therapeutic options that extend survival.

Cabometyx generated sales of $362.8 million in the first half of 2020, representing about 74.6% of total revenues. The uptake of the drug, since its approval (April 2016), has been strong. The company’s efforts to develop Cabometyx for various other indications are also encouraging. Label expansion of the drug for additional indications should further boost sales.

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