AstraZeneca Plc said it is withdrawing an application for European approval for an ovarian-cancer medicine following disagreement with regulatory authorities.
The decision won’t affect the ongoing development of the treatment, called cediranib, the Cambridge, England-based company said today in an e-mailed statement. The drugmaker had sought approval from the European Medicines Agency in June 2015 to sell the drug for use with platinum-based chemotherapy in adults with a type of ovarian cancer that’s relapsed.
“Following lengthy engagement with the EMA, it was clear that there would remain a difference of opinion on the overall benefit-risk of cediranib and on some of the study methods,” a company spokeswoman said. “So, on balance, we decided to withdraw the application for combination with chemotherapy to focus our attention on combination studies of cediranib with other medicines.”
Cediranib is being tested in late-stage trials in combination with AstraZeneca’s approved ovarian-cancer treatment Lynparza and the experimental durvalumab cancer therapy, she said.
AstraZeneca hasn’t submitted cediranib for approval for use with chemotherapy in any other markets, and the drug was only expected to bring in about $145 million in sales by 2022, according to data compiled by Bloomberg.