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Glaxo Seeks Votrient Label Expansion in EU

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GlaxoSmithKline (GSK) recently announced that it has submitted a variation to the Marketing Authorisation for its oncology drug, Votrient to the European Medicines Agency. Glaxo is looking to get Votrient approved as maintenance therapy in women suffering from stage II-IV ovarian, fallopian tube or primary peritoneal cancer, whose disease did not worsen after receiving first-line chemotherapy treatment.

In Jun 2013, the company had announced encouraging data from a phase III trial (n = 940) on Votrient. The randomized, double-blind, placebo-controlled trial evaluated the use of Votrient in women suffering from advanced epithelial ovarian cancer.

The study met its primary endpoint of progression free survival (PFS/the time a patient lived without worsening of their disease). In the Votrient arm of the study, median PFS of 17.9 months was observed as compared to 12.3 months in the placebo arm, representing an improvement of 5.6 months. It was observed that treatment with Votrient reduced the risk of the disease worsening by 23%.

The company said that there were insufficient events to estimate median overall survival (:OS) at the time of data cut off. However, no difference in survival was found between the two arms of the trial in the interim analysis.

Glaxo plans to submit the marketing applications for the approval of Votrient in the ovarian cancer indication across the globe. Votrient is already marketed for the treatment of patients with advanced renal cell carcinoma. Last year, the drug’s label was expanded to include advanced soft tissue sarcoma.

In recent quarters, Glaxo’s oncology portfolio received a boost when two melanoma drugs, Tafinlar and Mekinist, gained approval from the U.S. Food and Drug Administration. While Tafinlar was approved for use in BRAF V600E mutation-positive unresectable or metastatic melanoma patients, Mekinist received clearance for the treatment of patients suffering from unresectable or metastatic melanoma with BRAF V600E or V600K mutations.

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. However, generic competition faced by Glaxo remains a concern. Companies that currently look attractive include Actelion Ltd. (ALIOF), Biogen Idec Inc. (BIIB) and Gilead Sciences Inc. (GILD), carrying a Zacks Rank #1 (Strong Buy).

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