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First-in-class cancer drug approved to fight melanoma

The US Food and Drug Administration (FDA) has approved the first cancer drug to inhibit a protein — called MEK — that acts in a pathway that fuels tumour growth. The drug, called Mekinist (trametinib), was approved on 29 May for use in advanced melanomas with specific mutations. Other MEK-targeting drugs are being studied in a wide range of tumours, including lung and thyroid cancers.

The FDA approved Mekinist together with another drug, called Tafinlar (dabrafenib), which targets cancer-driving mutant forms of a protein called BRAF. The agency also approved a medical test for those BRAF mutations. BRAF inhibitors, one of which is already on the market, elicit rapid and dramatic responses, in some cases wiping away nearly all signs of the disease. But the responses are short-lived, and the drugs boost survival by only a few months.

Hopes are high that Mekinist and Tafinlar, both made by GlaxoSmithKline, will eventually be approved for use in combination — and that the combination will lengthen patient survival more than either drug would individually. GlaxoSmithKline says that it will file for FDA approval of that combination in the coming months. Meanwhile, Mekinist will cost US$8,700 per month, and Tafinlar $7,600 per month, wholesale, putting both drugs just shy of the growing ‘$10,000-a-month club’ for cancer drugs.

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    Jim Woodgett said:

    MEK discovered in nineteen eighties. Potential use of inhibitors as anti-cancer target in nineteen nineties. Precise tumour targeting in 2000’s. An excellent real life example of the chain of events associated with discovery to clinic that demonstrates the need for balance in research funding and avoidance of overly optimistic acceleration/promises. Average grant term: 3.7 years.

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    Gerry Atrickseeeker said:

    It is great to hear about the approval of a new drug for metastatic melanoma, one of the most lethal forms of cancer. However, as with most new anti-cancer drugs, the projected price tag is absurd. We need some fundamental changes in the way drugs, particularly anticancer drugs, are discovered and developed. If it can’t be done at reasonable cost by the current profit-driven, ultra free market model, then perhaps new models are in order.

    http://scienceforthefuture.blogspot.com/2013/05/horns-of-dilemma-value-to-cancer.html

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    Vladimir Ivanov said:

    In spite of certain optimism, it is possible to predict only transient and modest effects of MEK inhibitors alone for a general treatment of melanoma. These inhibitors induce the G1 arrest of cell cycle without apoptosis, but with the subsequent slow necrosis of cancer cells. In contrast, there are numerous data demonstrating strong effects of combined treatment of MEK inhibitors and PI3K-AKT inhibitors on induction of melanoma apoptosis both in cell culture conditions and in animal models. Hopefully, appropriate combined treatment of melanoma will be the next stage in the fight against this cancer.

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