Dive Brief:
- AstraZeneca withdrew an application to the European Medicines Agency for an ovarian-cancer drug, citing unresolved regulatory questions about the medication well into its regulatory process.
- The English drugmaker submitted cediranib in June 2015 for approval in the EU to be used as part of a chemotherapy protocol in adults with platinum-sensitive relapsed ovarian cancer.
- The decision does not affect AstraZeneca's plans for the drug in other indications. The company noted that it intends to continue developing cediranib in combination with its other medications.
Dive Insight:
The cediranib filing was supported by data from ICON6, a two-stage Phase III trial that was conducted in the UK, Australia, Canada and New Zealand. After questions from the EMA’s Committee for Medicinal Products for Human Use late in the regulatory process, AstraZeneca chose to withdraw the applicaiton.
"The decision to withdraw the MAA was based on outstanding health authority questions that remain at this late stage of the review process,” AstraZeneca said in a statement.
AstraZeneca did not reveal in its statement the questions that were raised, nor did EMA respond to a question.
Cediranib, when given orally with chemotherapy, and continued as a maintenance drug, “yielded a meaningful improvement in progression free survival in women with recurrent platinum-sensitive ovarian cancer, albeit with added toxic effects,” according to the trial results. The study noted that the drug “could provide women with a new therapeutic option for recurrent ovarian cancer.”
AstraZeneca said it has not made additional regulatory submissions for cediranib in this indication in any other markets. Although AstraZeneca noted, “Cediranib remains an important part of AstraZeneca’s ovarian cancer medicine pipeline.”
Among the other options for cediranib could be with company’s ovarian cancer treatment, Lynparza (olaparib). In May, AstraZeneca said it was confident in Lyparza’s clinical actions in a range of tumor types, including ovarian cancer. However, a study of Lynparza, compared with paclitaxel chemotherapy, compared with the chemotherapy alone, did not meet the primary survival endpoint in a Phase 3 study in advanced gastric cancer patients.
In reacting to its decision concerning cediranib, the company maintained “it 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.”
Cediranib is a multi-vascular endothelial growth factor receptor (VEGFR) inhibitor that prevents blood vessels from growing and slows down the spread of the cancer.