Mekinist plus tafinlar approved for late-stage melanoma

(HealthDay)—The U.S. Food and Drug Administration on Friday approved Mekinist for use with another drug, Tafinlar, to treat advanced melanoma that is spreading or cannot be removed by surgery.

Melanoma is the most deadly form of , accounting for an estimated 9,480 American deaths last year, the FDA said Friday in a news release. Mekinist (trametinib) 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 , 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 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 swelling of the arms and feet. More serious adverse reactions included bleeding, blood clots, heart failure, and skin and eye problems.

The 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: The FDA has more about this approval.

add to favorites email to friend print save as pdf

Related Stories

New drugs, diagnostic approved for advanced melanoma

May 29, 2013

(HealthDay)—Two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), have been approved by the U.S. Food and Drug Administration to treat advanced melanoma, the most dangerous form of skin cancer.

Afinitor approved for advanced breast cancer

Jul 23, 2012

(HealthDay) -- Afinitor (everolimus) has been approved in combination with the drug exemestane to treat postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer, the U.S. Food ...

Nexavar approval expanded for common thyroid cancer

Nov 24, 2013

(HealthDay)—U.S. Food and Drug Administration approval for the anti-cancer drug Nexavar (sorafenib) has been expanded to include late-stage differentiated thyroid cancer, the most common type of thyroid ...

Imbruvica approved for mantle cell lymphoma

Nov 13, 2013

(HealthDay)—Imbruvica (ibrutinib) has been approved by the U.S. Food and Drug Administration to treat mantle cell lymphoma (MCL), a rare but aggressive form of blood cancer.

Zaltrap approved for advanced colorectal cancer

Aug 04, 2012

(HealthDay) -- Zaltrap (ziv-afilbercept) has been approved by the U.S. Food and Drug Administration in combination with a FOLFIRI chemotherapy regimen for adults with advanced metastatic (spreading) colorectal cancer, the ...

Recommended for you

ACG: Recent increase in incidence of young-onset CRC

6 hours ago

(HealthDay)—The incidence of young-onset colorectal cancer (CRC) is increasing, and the disease is more aggressive pathologically. These findings are being presented at the annual meeting of the American ...

User comments