AZ withdraws EU ovarian cancer drug filing
AstraZeneca has withdrawn a European filing for its ovarian cancer drug, cediranib.
AZ filed the drug with the European Medicines Agency’s CHMP scientific committee in June last year.
The Anglo-Swedish company was attempting to get the drug approved in combination with platinum-based chemotherapy followed by maintenance monotherapy, for adults with platinum-sensitive relapsed ovarian cancer, including fallopian tube or primary peritoneal sub types.
The company said it had decided to withdraw the filing because of outstanding questions raised by the EMA during the late stage of the review process.
AZ did not provide details of the outstanding questions, but said cediranib remains an “important part” of its ovarian cancer pipeline.
The decision does not affect an ongoing development programme testing cediranib in combination with the company’s existing and pipeline medicines.
AZ’s filing for cediranib was supported by data from ICON6, a phase 3 trial led by investigators from University College London (UCL) and the Medical Research Council.
The company has not made additional filings for cediranib in this indication in any other markets.
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.
AZ’s Lynparza is a PARP inhibitor is already marketed in some forms of ovarian cancer. The company is trying to develop a new generation of drugs in order to hit a sales target of $45 billion by 2023.
Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.