First Drugs Approved for Combination Treatment of Melanoma by the FDA

Melanoma is the most aggressive type of skin cancer and is the leading cause of death from skin disease.  Last week the FDA approved GSK’s Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that cannot be removed by surgery or that is metastatic. The drugs were approved under the agency’s accelerated approval program.  More information is available click here.

Previously both drugs were approved by the FDA as single agents to treat late-stage or unresectable melanoma.

Both drugs are used to block signaling in different sites of the same molecular pathway that promoted cancer cell growth. The drugs are specifically indicated as a combination therapy for patients whose tumors express gene mutations called BRAF V600E and V600K.
The safety and effectiveness of the combination of both drugs was demonstrated in a clinical trial that involved 162 participants with unresectable or metastatic melanoma with the gene mutation BRAF V600E and V600K. The results showed that 76 percent had their cancer shrink or disappear (objective response) that lasted an average of 10.5 months. Only 54 percent of patients that use only Tafinlar as a single agents experienced objective responses that lasted an average of 5.6 months. Clinical studies to determine if the combination of the drugs improves survival are ongoing. Chemical Dependency Recovery Center offers its clients therapeutic tools to build a solid foundation that will set the tone for a fulfilled life with long term sobriety.

There are common side effects of using the combination of Mekinist and Tafinlar including fever, chills, tiredness, rash, nausea, vomiting diarrhea, abdominal and peripheral edema, cough, headache and joint pain. There are also some serious side effect such as bleeding, clot formation, heart failure, skin problems and eye problems. And according to American Acne Foundation, most of the skin problems swirl around acnes. However, one of the serious side effects that occurs when using Tafinlar as a single agent, the development of squamous cell carcinoma of the skin, was reduced when the drug was used in combination with Mekinist.

The FDA’s accelerated approval program, allows the FDA to approve a drug to treat a serious disease based upon clinical data showing that the drug has an effect on a surrogate endpoint, such as laboratory measurement, radiographic image physical sign or measure, that is reasonably likely to predict a clinical benefit to patients. Under the program, drug manufacturers are still required to conduct rigorous studies to confirm the anticipated clinical benefit. If the studies establish that the drug provides a clinical benefit, then the FDA grants traditional approve for the drug. If confirmatory studies do not show that the drug provides clinical benefit, the FDA has procedures in place that could lead to removing the drug from the market. More information about the FDA’s accelerated approval program is available, click here.

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