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GSK halts bid for Votrient maintenance use

Pulls European application for indication in advanced ovarian cancer

GlaxoSmithKline GSKGlaxoSmithKline (GSK) has abandoned its bid to extend Votrient's (pazopanib) in advanced ovarian cancer, withdrawing an EU licence application and abandoning development in any other countries.  

The company decided its data could not support a positive risk/benefit profile for Votrient as a maintenance treatment for ovarian, fallopian tube or primary peritoneal cancer in women who have not progressed after receiving first-line chemotherapy.  

Votrient is already approved in renal cell carcinoma and certain types of soft tissue sarcoma and last year grew its sales 56 per cent to £144m (about $240m), but the decision is a knock to GSK's ambitions for the drug.  

Dr Rafael Amado, head of oncology R&D at GSK, said there remains significant unmet need in the treatment of advanced ovarian cancer.  

He added: “We believe that, in spite of the improvement in progression free survival observed in our phase III study, the totality of the evidence including these more mature overall survival data, do not support an overall positive benefit-risk for Votrient in this indication.  

“While we are disappointed by these results, we will progress additional analyses which may add to the body of scientific evidence in this disease setting.”  

GSK said data from its planned second interim overall survival analysis of the study did not support the overall risk/benefit profile for Votrient's application in the indication.  

The hazard ratio for overall survival in the trial - which compared Votrient to placebo - was 1.076, and GSK said the data behind that finding would be submitted for presentation at an upcoming medical congress.

Article by
Dominic Tyer

1st April 2014

From: Sales



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