FDA Approves Mekinist Plus Tafinlar for Late-Stage Melanoma
Newly approved for people who have certain mutations in the BRAF V600E and V600K genes
FRIDAY, Jan. 10, 2014 (HealthDay News) -- The U.S. Food and Drug Administration has approved Mekinist for use with another drug, Tafinlar, to treat advanced melanoma that is metastatic or unresectable.
Mekinist is newly approved to be used in combination with Tafinlar (dabrafenib). Both drugs were first sanctioned in May 2013 to be used by themselves to battle advanced melanoma, the agency said. The combination therapy is newly approved for people who have certain mutations in the BRAF V600E and V600K genes, the FDA said. About half of melanoma cases have the mutated genes.
The combination therapy was clinically evaluated in 162 people. Of those treated, 78 percent had their cancer shrink or disappear for an average of 10.5 months, the agency said.
The most common side effects included fever, chills, rash, fatigue, nausea, diarrhea, abdominal pain, and peripheral edema. More serious adverse reactions included bleeding, blood clots, heart failure, and skin and eye problems. The drug combination can cause infertility and birth defects, the agency said, warning men and women of child-bearing age.
Both drugs are marketed by GlaxoSmithKline, based in Research Triangle Park, N.C.
More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm381159.htm )