AstraZeneca announced Wednesday that it will withdraw a European filing seeking approval of its oral multi-VEGF receptori nhibitor cediranib for certain patients with ovarian cancer. The company noted that the decision "was based on outstanding questions raised by the European Medicines Agency (EMA) at this late stage of the review process." The application, submitted in June last year, sought clearance for cediranib in combination with platinum-based chemotherapy, followed by maintenance monotherapy, to treat adults with platinum-sensitive relapsed ovarian cancer.
AstraZeneca, which noted it has not made additional regulatory submissions for cediranib in this indication in any other markets, said its filing was supported by data from the Phase III ICON6 study. Results demonstrated that cediranib led to significant improvements in progression-free survival (PFS) and overall survival, when given during and after chemotherapy, compared with chemotherapy alone. However, the EMA raised questions over whether the drug's side effects, such as diarrhoea and fatigue, outweighed its benefits, and also questioned the way the clinical trial was conducted.
A spokesperson for AstraZeneca said "we absolutely believe the benefits outweighed the side effects," noting the company "also went back to the EMA with the Medical Research Council, which led the study, addressing the points they raised about our methods and analysis." Nevertheless, "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," the spokesperson explained, adding that "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 currently in Phase III testing as part of a combination regimen with AstraZeneca's PARP inhibitor Lynparza (olaparib). In mid-stage study data unveiled in 2014, the combination of cediranib and Lynparza prolonged PFS by nearly two-fold compared to Lynparza alone in women with recurrent platinum-sensitive high-grade serous ovarian cancer. The company is also evaluating cediranib in combination with its experimental PD-L1 inhibitor durvalumab.
Analysts have forecast sales of about $145 million for cediranib by 2022.
To read more Top Story articles, click here.