AZ withdraws European filing for ovarian cancer therapy
pharmafile | September 22, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | AstraZeneca, EMA, cediranib, ovarian cancer
AstraZeneca is no longer seeker European approval for its oral multi-VEGF receptor inhibitor cediranib for treatment of ovarian cancer after withdrawing its filing for the drug.
The company cited “outstanding questions raised by the European Medicines Agency (EMA) at this late stage of the review process,” as reason for the withdrawal. The agency argued that the drug’s side effects, including diarrhoea and fatigue, outweighed its benefits, despite data from the manufacturer evidencing its efficacy in improving progression-free survival (PFS) and overall survival when used in combination with chemotherapy, compared with chemotherapy alone.
AstraZeneca originally filed for approval of the drug in June 2015 for treatment in combination with platinum-based chemotherapy, followed by maintenance monotherapy, to treat adults with platinum-sensitive relapsed ovarian cancer. Analysts say it could bring in $145 million for the company by 2022.
The drug is currently in Phase III testing as part of a combination regimen with AstraZeneca’s PARP inhibitor Lynparza (olaparib). The company is also evaluating cediranib in combination with its experimental PD-L1 inhibitor durvalumab.
In a statement, a spokesperson for AstraZeneca stated: “We absolutely believe the benefits outweighed the side effects. 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. Following lengthy engagement with the EMA, it was clear that there would remain a difference of opinion on the overall benefit-risk of cediranib and on some of the study methods. On balance, we decided to withdraw the application for combination with chemotherapy to focus our attention on combination studies of cediranib with other medicines.”
Matt Fellows
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