Breaking News

US Department of Labor releases informational copies of 2022 Form 5500 Series Annual Return/Report Two Men Wanted on Charges of Aggravated Sex Crimes Nabbed at the Progreso Port of Entry Secretary Walsh announces new partners, action plan, support for international worker voice initiative False Name Turns into Counterfeit U.S. Currency Discovery by Wellesley Island Border Patrol Agents US Department of Labor awards $5M to help fight workplace discrimination, harassment; empower working women in Nigeria, Liberia El Paso CBP Officers Apprehend Fugitive Wanted for Homicide US Department of Labor recovers more than $17K for illegally terminated employee after Publix Super Markets Inc. violates medical leave protections CBP Seizes Fentanyl and Methamphetamine at Presidio Port

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that it has withdrawn its application to the European Medicines Agency (EMA) for a variation to the Marketing Authorisation for Votrient® (pazopanib). This application, made in August 2013, was related to the additional indication for the 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 has taken the decision because the data from the planned second interim Overall Survival (OS) analysis of the phase III study did not support the overall benefit:risk for Votrient in this indication. The hazard ratio for OS was 1.076 (p=0.4985; 95% CI: 0.868; 1.333).These data will be submitted for presentation at an upcoming medical congress. GSK does not intend to progress further with this indication in other countries.

“There is significant unmet need in the treatment of advanced ovarian cancer”, said Dr 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. 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.”

The regulatory submission for Votrient in this indication was based on the results from AGO-OVAR-16 (VEG110655),  a randomised, double-blind, phase III, placebo-controlled study which evaluated the efficacy and safety of pazopanib monotherapy as compared with placebo in women with FIGO stage II-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease had not progressed after first-line chemotherapy. 

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please

Cautionary statement regarding forward-looking statements

Source link