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European Approval for Glaxo's Tafinlar

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GlaxoSmithKline (GSK - Free Report) recently announced that its melanoma drug, Tafinlar, has been cleared by the European Commission (EC). Tafinlar is indicated as a monotherapy for treating adults suffering from unresectable or metastatic melanoma with a BRAF V600 mutation.

However, Tafinlar is not recommended for patients suffering from wild-type BRAF melanoma. Additionally, a presence of BRAF V600 mutation should be confirmed in the melanoma patients using a validated test before prescribing Tafinlar.

The approval came on the basis of encouraging data from several multi-center global trials including the phase III BREAK-3 study.

We remind investors that Tafinlar received approval as monotherapy in the U.S. in May 2013. The U.S. Food and Drug Administration (FDA) approved Tafinlar for BRAF V600E mutation-positive unresectable or metastatic melanoma patients. However, the FDA did not recommend the use of Tafinlar for patients suffering from wild-type BRAF melanoma. The FDA also cited several warnings and precautions related to the use of Tafinlar, which can lead to fatal side effects including increasing the risk of developing new primary cutaneous malignancies.

Glaxo intends to launch the drug in the U.S. shortly. Currently approved melanoma drugs include Zelboraf and Yervoy.

Glaxo carries a Zacks Rank #3 (Hold). We are pleased with Glaxo’s label expansion efforts. Moreover, Glaxo boasts of a robust pipeline. A number of pipeline-related news is expected in the coming quarters. Given the declining sales from generic competition, we believe Glaxo’s pipeline must deliver.

Companies that currently look well-positioned include Actelion Ltd. and Gilead Sciences Inc. (GILD - Free Report) with a Zacks Rank #1 (Strong Buy) and Jazz Pharmaceuticals (JAZZ - Free Report) with a Zacks Rank #2 (Buy).

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