Exelixis obtains FDA approval for Cabometyx in combination therapy for frontline RCC

Exelixis (NASDAQ: EXEL) is charging the weekend on the rise. On Friday, the company announced that the Food and Drug Administration had approved its drug Cabometyx (also known as Cometriq) for the first-line treatment of patients with advanced renal cell carcinoma (RCC), in combination with Bristol Myers Squibbin (NYSE: BMY) Opdivo.

Approval is a major victory for Exelixis, as RCC is the most common form of kidney cancer. The company also pointed out that it is among the 10 most diagnosed cancers in the U.S.

Medical professionals conferring in the lobby of a hospital.

Image source: Getty Images.

The approval cycles of Cabometyx and Opdivo are closely aligned. Bristol Myers Squibb was approved by the FDA as a second-line treatment for RCC in late 2015. Cabometyx received the green light for the same indication in the following April.

The drug’s approval derives from a comparative study on the effects of a combination Cabometyx / Opdivo versus sunitinib – marketed by Pfizer under the Sutent brand. The drugs were tested in a phase 3 clinical trial with the aim of evaluating their effect on previously untreated advanced or metastatic CCR.

“As the only combination treatment regimen for double median progression-free survival and objective response rate compared to sunitinib, while significantly improving overall survival, we are thrilled that Cabometyx in combination with Opdivo is now available for the first-line treatment of patients with advanced kidney cancer disease, “said Exelixis CEO Michael Morrissey.

Shares in Exelixis and Bristol Myers Squibb increased with the news, although the latter rose more modestly. Exelixis closed on Friday almost 3.9% higher, compared to a 0.3% drop in the S&P 500 index, while its pair rose 0.6% on the day.

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