AstraZeneca announced 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).
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 health authority questions that remain at this late stage of the review process. The MAA for cediranib was supported by data from ICON6, a phase III trial led by the Medical Research Council (MRC) Clinical Trials Unit at UCL. AstraZeneca has not made additional regulatory submissions for cediranib in this indication in any other markets.
ICON6 was a randomised, three-arm and two-stage double-blind placebo-controlled phase III trial conducted in UK, Canada, Australia, New Zealand and Spain. It was designed to evaluate the safety and efficacy of platinum-based chemotherapy in combination with cediranib in women with platinum-sensitive relapsed ovarian cancer. The trial was developed by the International Collaboration for Ovarian Neoplasia (ICON) and Gynecologic Cancer InterGroup (GCIG) and led by the MRC Clinical Trials Unit at University College London.
Cediranib is a novel, orally administered multi-Vascular Endothelial Growth Factor receptor (VEGFR) inhibitor which is currently being tested as a maintenance treatment in patients with platinum-sensitive relapsed (PSR) ovarian cancer. Cediranib inhibits tumour growth by stopping blood flow to the tumour site.
