Melanoma drug combination approved for sale in the US

Metastatic or unresectable melanoma has a new treatment option in the US after the FDA approved the marketing of the combination of GlaxoSmithKline drugs Tafinlar (dabrafenib) and Mekinist (trametinib).

 “This approval marks another key moment in what continues to be a rapid evolution of the treatment landscape for metastatic melanoma patients. Combining agents that target different mechanisms regulating the growth of cancer cells is one of the promising areas in cancer research.”

 
Dr. Paolo Paoletti, president, oncology, GlaxoSmithKline.
 

The drug combination was successful in trials against BRAF V600E or V600K mutation-positive, histologically confirmed stage 3c or 4 melanoma. The genetics must be confirmed by an FDA-approved companion diagnostic, the THxID BRAF test, before the new combination treatment can be offered.

In other FDA news today, the US regulator has warned consumers not to overuse laxatives. It has issued a drug safety announcement on OTC sodium phosphate drugs for constipation, saying that more than one dose in 24 hours, which is contrary to labelling, “can cause rare but serious harm to the kidneys and heart, and even death”.

 

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Related news:

New therapy approved to treat advanced melanoma (Daily Rx).

FDA approves GSK’s combo cancer treatment (PMLiVE)

GSK gains accelerated FDA approval for combination use of Mekinist (trametinib) and Tafinlar (dabrafenib) (The Wall Street Journal/GSK press release)

Reference links:

FDA approves two drugs, companion diagnostic test for advanced skin cancer (FDA press release).

FDA warns of possible harm from exceeding recommended dose of over-the-counter sodium phosphate products to treat constipation (FDA safety announcement)

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