Exelixis (NASDAQ: EXEL) load the weekend on a high note. The company announced Friday that the Food and Drug Administration has approved its drug Cabometyx (also known as Cometriq) for first-class treatment of patients with advanced renal carcinoma (RCC), in combination with Bristol Myers Squibbsay (NYSE: BMY) Opdivo.
The approval is a big win for Exelixis, as RCC is the most common form of kidney cancer. The company also pointed out that it is one of the top 10 most diagnosed cancers in the US
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The approval cycles of Cabometyx and Opdivo are now joining. The drug from Bristol Myers Squibb was approved by the FDA in late 2015 as a second-line treatment for RCC. Cabometyx got its green light for the same indication the following year.
The approval of the drug was obtained from a comparative study on the effects of a Cabometyx / Opdivo combination against sunitinib – marketed by Pfizer under the trade name Sutent. In a Phase 3 clinical trial, the drug is continuously focused on evaluating its effect on previously untreated advanced or metastatic RCC.
“As the only combination treatment regimen that doubles the average median demand-free survival and the objective response rate compared to sunitinib, while also significantly improving overall survival, we are excited that Cabometyx in combination with Opdivo is now available for first-class treatment of renal cancer patients.” Michael Morrissey, CEO of Exelixis, said.
Both the Exelixis and Bristol Myers Squibb shares increased with the news, although the latter had a modest rise. Exelixis closed nearly 3.9% higher on Friday, down 0.3% S&P 500 index, while its counterpart enjoyed a bump of 0.6% on the day.