) 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
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
Gilead Sciences Inc.
) with a Zacks Rank #1 (Strong Buy) and
) with a Zacks Rank #2 (Buy).
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