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FDA Approves Two Glaxo Skin Cancer Treatments


U.S. regulators have approved two new GlaxoSmithKline PLC (GSK, GSK.LN) treatments for an aggressive form of skin cancer.
The U.S. Food and Drug Administration approved both dabrafenib, marketed as Tafinlar, and trametinib, or Mekinist, to treat melanoma.
The drugs are both oral treatments for adult patients with melanoma that can't be surgically removed or has spread to other parts of the body.
"With today's FDA approvals, GSK can now offer two new single-agent therapies to selected patients who have metastatic melanoma, a devastating disease with very low survival rates and few treatment options," said Paolo Paoletti, president of GSK's oncology unit.
Around half of patients with metastatic melanoma have a BRAF mutation, a change in a gene that can allow melanoma to grow and spread. Both Tafinlar and Mekinist are approved for patients with the BRAF V600E mutation, and Mekinist is also approved for patients with the BRAF V600K mutation.
Tafinlar can cause serious side effects, including an increased risks of developing new skin cancers, severe fevers and severe eye problems. Mekinist can cause heart failure, lung disease and other health problems.
Glaxo will make the drugs available for sale by the early third quarter. The British drug company has been pushing hard to bring new drugs to market this year.
The company's American depositary shares were off a penny at $52 in after-hours trading. Through the close, the equity was up 20% since the start of the year.

Write to Kristin Jones at [e-mail]

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(END) Dow Jones Newswires
May 29, 2013 18:45 ET (22:45 GMT)
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