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AZ withdraws EU filing for ovarian cancer drug cediranib

Maintains cediranib’s value as a combination therapy despite EMA information request

AstraZeneca has been forced to pull a regulatory filing for a targeted drug for ovarian cancer following an EMA request for more information.

Without going into details, AZ said that there are "outstanding health authority questions" in the review of cediranib, an oral multi-vascular endothelial growth factor (VEGF) receptor inhibitor, that meant it had no choice but to withdraw the application.

The UK-based pharma group was quick to say that the decision does not spell the end of cediranib, which according to a statement "remains an important part of AZ's ovarian cancer medicine pipeline" as a component of combination therapies.

AZ filed cediranib with the EMA in June 2015, seeking approval for the drug in combination with platinum-based chemotherapy - followed by maintenance as a monotherapy - in adults with platinum-sensitive relapsed ovarian cancer.

The application was based on the results of the phase III ICON6 trial, which showed that adding cediranib to chemotherapy resulted in an approximately three-month gain in progression-free survival (PFS) compared to chemotherapy alone.

Compliance with AZ's drug was poor however, particularly during the maintenance phase, mainly because of side effects, and it is understood that the EMA was concerned about the risk-to-benefit ratio of the drug. The results of the trial were published earlier this year in The Lancet.

The drug is not considered a major player in AZ's cancer pipeline in its own right, having previously failed a phase III trial in non-small cell lung cancer (NSCLC) as well as a late-stage trial in metastatic colorectal cancer in which it was compared to Roche's injectable VEGF inhibitor Avastin (bevacizumab).

While its role as a monotherapy is ended, cediranib remains an important component of AZ's combination therapy strategy in ovarian cancer. A trial reported in 2014 showed that cediranib plus PARP inhibitor Lynparza (olaparib) was able to nearly double progression-free survival (PFS) compared to olaparib alone in a phase II trial. It is also being tested in combination with AZ's immuno-oncology drug durvalumab.

"This decision does not affect the ongoing primary development programme testing cediranib as a combination treatment alongside the company's existing and potential medicines," stressed AZ.

Article by
Phil Taylor

22nd September 2016

From: Regulatory



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