Exelixis has won the U.S. Food and Drug Administration’s expanded approval to use its cancer drug CABOMETYX on previously untreated kidney cancer patients, the company said Tuesday.
“Today’s approval of CABOMETYX is a true win for patients in the U.S. with advanced renal cell carcinoma who now have a new first-line treatment option,” CEO Michael M. Morrissey said.
The U.S. regulatory agency approved CABOMETYX (cabozantinib) last year as a second-line treatment for advanced renal cell carcinoma (RCC), the most common form of kidney cancer. FDA has just approved the drug to treat previously treated RCC patients in Korea and four other countries.
The drug proved efficacy in a phase 2 CABOSUN trial, in which cabozantinib improved progression-free survival over Pfizer’s Sutent (sunitinib), it said. Data showed Exelixis’ drug slashed the rate of disease progression or death by 50 percent, according to an independent data review.
As for side effects, around 70 percent of patients taking CABOMETYX and 65 percent of those taking Sutent experienced Grade 3-4 adverse reactions that include hypertension, diarrhea, and hyponatremia, among others, the company said.
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