Glaxo's Two Cancer Drugs Get EU Nod - Analyst Blog

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GlaxoSmithKline ( GSK ) announced that its melanoma drug, Mekinist has been cleared by the European Commission (EC) as a single agent for the treatment of adults suffering from unresectable or metastatic melanoma with a BRAF V600 mutation. We note that Mekinist is only indicated for patients who have confirmation of a BRAF V600 mutation using a validated test and is not indicated for patients who have received prior BRAF inhibitor treatment.

The EC recommendation was not surprising as the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion regarding the approval of Mekinist in Apr 2014.

Mekinist, which generated revenues of £13 million in the first quarter of 2014, is currently approved in the U.S. both as monotherapy and in combination with Tafinlar, another melanoma drug at Glaxo.

Meanwhile, Glaxo and partner Genmab announced that the EC has approved their cancer drug, Arzerra, for an additional indication. Arzerra is now approved in the EU in combination with Glaxo's Leukeran (chlorambucil) or Teva Pharmaceutical Industries Limited 's ( TEVA ) Treanda (bendamustine) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and who are not eligible for Sanofi 's ( SNY ) Fludara (fludarabine)-based therapy.

In this case too, the CHMP had issued a positive recommendation.

Arzerra is already approved in the EU for the treatment of patients with CLL refractory to Sanofi's Campath (alemtuzumab) and Fludara (fludarabine). We note that earlier this year, the FDA also approved Arzerra in combination with Leukeran in treatment-naive CLL patients for whom Fludara-based therapy is not suitable.

We believe that Arzerra's label expansion will significantly increase the number of patients targeted by the drug and boost its sales. Glaxo reported Arzerra revenues of approximately £16 million in the first quarter of 2014.

Glaxo carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include Allergan ( AGN ) carrying a Zacks Rank #2 (Buy).


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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: EC , CHMP , SNY , AGN , TEVA

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