GSK’s Votrient fails in ovarian cancer
GlaxoSmithKline has withdrawn its European application for Votrient for use in ovarian cancer, after phase III trials failed to prove the drug’s effectiveness.
Votrient (pazopanib) is already licensed to treat advanced/metastatic renal cell carcinoma and advanced soft tissue sarcomas, and the company had hoped to expand its use into another hard-to-treat cancer.
The application was for maintenance treatment of women with FIGO stage II-IV epithelial ovarian, fallopian tube or primary peritoneal cancer who had not progressed after receiving first-line chemotherapy.
GSK says decision came after a second interim Overall Survival (OS) analysis of the phase III study did not support the overall benefit:risk for Votrient in this indication. The company says the data will be submitted for presentation at an upcoming medical congress, and confirmed it would not pursue the indication in any other countries.
Other new treatments
A number of other new treatments have been emerging for ovarian cancer. Most notable among these is Roche’s Avastin, which received EU approval for the treatment of newly diagnosed, advanced ovarian cancer in 2011.
However it wasn’t until last October that trials proved that Avastin significantly improved overall survival compared to standard treatment. A phase III trial showed women at highest risk of their cancer recurring given Avastin in combination with chemotherapy, and then continued maintenance Avastin, lived on average 9.4 months longer than those on chemotherapy alone (median OS 39.7 months vs. 30.3 months).
These results could change the opinion of UK cost effectiveness watchdog NICE, which does not currently recommend the drug for use on the NHS.
The EMA is currently reviewing another drug for use in ovarian cancer – AstraZeneca’s olaparib. The drug has been filed for use as a maintenance treatment in a sub-group of patients with BRCA mutated platinum-sensitive relapsed serous ovarian cancer.
Finally, Amgen also has its own contender, trebananib, which showed some promise in phase III trials published in 2013.
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