AstraZeneca PLC Yanks Ovarian Cancer EU Application After 'Differences Of Opinion' With Regulators

21 September 2016

AstraZeneca today 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.

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.

NOTES TO EDITORS

About ICON6
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.1

About cediranib
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.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Respiratory and Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The company is also active in inflammation, infection and neuroscience through numerous collaborations. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com