GlaxoSmithKline: Two melanoma products from GSK approved simultaneously

NEUTRAL, Fair Value  1940p (+12%)

News published on May Thursday 30, 2013
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The FDA yesterday approved two new oral treatments from GSK for metastatic or unresectable BRAF V600 mutated melanoma in adult patients. First approval was awaited because the PDUFA date for the BRAF inhibitor dabrafenib (to be named Tafinlar) was set for June 2nd. The second, i.e. the MEK inhibitor trametinib (now called Mekinist) is a bit more surprising as the review was extended by
3 months, with a new PDUFA date on September 3rd. Note that companion diagnostic test from bio-Mérieux was approved simultaneously as THxID-BRAF. Tafinlar will compete with Roche’s Zelboraf whereas Mekinist is first in class. GSK also disclosed positive data for Arzerra in 1st line CLL. The Oncology franchise from GSK which has not performed well for years is on the verge of a true revival.


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