AstraZeneca is pulling back its application to market ovarian cancer drug cediranib in Europe, marking the end of the line for the drug in combination was chemotherapy.
The firm was seeking approval for use of its oral VEGFR inhibitor in combination with platinum-based chemotherapy followed by maintenance monotherapy to treat adult patients with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal sub types).
The marketing application for the drug was filed in June last year on the back of data from ICON6, a randomised, three-arm and two-stage double-blind placebo-controlled Phase III trial conducted in UK, Canada, Australia, New Zealand and Spain. However, in a statement on its website the firm said it decided to withdraw the application because of “outstanding questions raised by the European Medicines Agency (EMA) at this late stage of the review process.”
“In the end there were differences of opinion with the regulator,” a company spokesperson told The Independent. “We went back and forth but sometimes you just can’t change someone’s mind.”
The EMA had reportedly had concerns over the trial and whether drug’s potential side effects outweighed its benefit.
“We absolutely believe the benefits outweighed the side effects,” the spokesman told the paper. “We also went back to the EMA with the Medical Research Council, which led the study, addressing the points they raised about our methods and analysis, but if you have a difference of opinion you have to take a view as to where it is going to go.”
AstraZeneca stressed that cediranib remains “an important part” of its ovarian cancer medicine pipeline, and that the decision does not affect the ongoing primary development programme testing the drug in combination with its existing and potential medicines.