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Exelixis (EXEL) Wins FDA Nod for Cabometyx + Opdivo in RCC

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Zacks Equity Research
·2 min read
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Exelixis, Inc. EXEL and partner Bristol-Myers Squibb Company BMY announced that the FDA approved the former’s lead drug, Cabometyx, in combination with the latter’s immuno-oncology drug, Opdivo, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The approval came ahead of the Prescription Drug User Fee Act action date of Feb 20, 2021.

The FDA approval was based on positive results of the CheckMate -9ER study, wherein the combination of Cabometyx and Opdivo significantly improved overall survival while doubling progression-free survival and objective response rate compared to Pfizer’s PFE Sutent as a first-line treatment for patients with advanced RCC, one of the most common forms of kidney cancer.

The approval will be a significant boost for Cabometyx. This market represents huge potential, as an estimated 15,000 patients with advanced RCC are eligible for first-line treatment every year in the United States, with immune checkpoint inhibitor (ICI) combination therapy consisting of approximately 80% of that market.

Of late, the focus in this space has shifted to combination treatment as the first-line option for RCC patients. Given its market potential, most pharma/biotech bigwigs are scurrying to grab a larger chunk of this pie.

Merck’s MRK immuno-oncology drug, Keytruda, plus Inlyta is also approved for the first-line treatment of patients with advanced RCC.

We remind investors that the tablet formulation of cabozantinib is approved as Cabometyx in the United States for the treatment of patients with advanced RCC and those with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar.

Shares of the company have increased 24.8% in the past year compared with the industry’s growth of 18.1%. Shares gained 3.8% on the news.

Meanwhile, the company plans to evaluate Cabometyx further for additional indications. Revenues generated from approved indications of the drug are expected to support its pipeline progress.

Exelixis currently carries a Zacks Rank #4 (Sell). 

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Pfizer Inc. (PFE) : Free Stock Analysis Report
 
Merck & Co., Inc. (MRK) : Free Stock Analysis Report
 
Exelixis, Inc. (EXEL) : Free Stock Analysis Report
 
Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report
 
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