On September 21, 2016 AstraZeneca reported its decision to withdraw the Marketing Authorisation Application (MAA) submitted to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2015 for cediranib in combination with platinum-based chemotherapy followed by maintenance monotherapy for the treatment of adult patients with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal sub types) (Press release, AstraZeneca, SEP 21, 2016, View Source [SID:SID1234515263]).

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Cediranib remains an important part of AstraZeneca’s ovarian cancer medicine pipeline and this decision does not affect the ongoing primary development programme testing cediranib as a combination treatment alongside the Company’s existing and potential medicines.

The decision to withdraw the MAA was based on outstanding questions raised by the European Medicines Agency (EMA) at this late stage of the review process. The MAA for cediranib was supported by data from ICON6, a Phase III trial led by investigators from University College London (UCL) and the Medical Research Council (MRC). AstraZeneca has not made additional regulatory submissions for cediranib in this indication in any other markets.

AstraZeneca is committed to enhancing treatment options for patients with ovarian cancer, including developing chemotherapy-free alternatives to help delay or avoid the use of platinum-based chemotherapies.