Votrient’s extended licence application ditched
pharmafile | April 1, 2014 | News story | Sales and Marketing | EMA, Europe, GSK, ovarian, votrient kidney cancer
GlaxoSmithKline admits it is ‘disappointed’ after abandoning its attempt to extend kidney cancer drug Votrient’s licence to take in ovarian cancer.
The company has withdrawn an application to the European Medicines Agency for a variation to the marketing authorisation for Votrient (pazopanib) after deciding that the risk to patients did not stack up.
The EMA application, made last August, was for the maintenance treatment of women with FIGO stage II-IV epithelial ovarian, fallopian tube or primary peritoneal cancer whose disease had not progressed after first-line chemotherapy.
The submission was based on results from AGO-OVAR-16 (VEG110655), a Phase III study which tested Votrient’s efficacy and safety as monotherapy in this patient group compared with placebo.
GSK says data from the planned second interim overall survival (OS) analysis from this trial simply “did not support the overall benefit/risk for Votrient in this indication”.
It is a blow for GSK, which also says it will ditch attempts in other countries to extend the licence to cover ovarian cancer, and will submit the relevant data for presentation at an upcoming medical congress.
“There is significant unmet need in the treatment of advanced ovarian cancer”, said Rafael Amado, head of oncology R&D at GSK. “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 OS data, do not support an overall positive benefit/risk for Votrient in this indication.”
However, GSK says it will use the results in a bid to understand more about the condition and its possible treatments.
Amado concluded: “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.”
Votrient gained its most recent European licence in 2012 for patients with advanced soft tissue sarcoma who have received prior chemotherapy or have progressed within 12 months after adjuvant therapy.
Adam Hill
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