|AstraZeneca's headquarters in London--Courtesy of AstraZeneca|
European regulators have recommended an early approval for AstraZeneca's ($AZN) new ovarian cancer treatment, welcome news for the company as it defends rosy sales estimates for its oncology pipeline.
The European Medicines Agency has voted in favor of the AstraZeneca's olaparib, which would sell as Lynparza. The group's recommendation is generally followed by a full continental approval in about three months, a move that would clear the drug for the treatment of patients with platinum-sensitive ovarian cancer and BRCA mutations.
The EMA's vote is based on a Phase II trial in which olaparib led to progression-free survival (PFS) of 11.2 months versus 4.3 months on placebo, data that weren't enough to sway U.S. regulators considering an early approval of their own.
Over the summer, AstraZeneca presented the same results to a panel of FDA experts, and the group picked apart olaparib's potential, taking issue with the its failure to significantly improve overall survival, pointing to a few alarming adverse events and expressing doubts in the reliability of its PFS data. The committee voted 11-2 against recommending an early approval for the drug, meaning AstraZeneca will likely have to complete its ongoing Phase III study on olaparib before it can make its way to the U.S. market.
The company maintains that olaparib, a PARP inhibitor, can eventually bring in $2 billion a year in sales, a figure unveiled earlier this year as the U.K. drugmaker worked to fend off unwelcome advances from Pfizer ($PFE). AstraZeneca has even higher hopes for MEDI4736, a PD-L1 therapy the company believes will top out at $6.5 billion a year; and AZD9291, a Phase I lung cancer treatment tabbed to peak at $3 billion.
For each of AstraZeneca's oncology contenders, reaching those lofty goals will depend on success across a range of cancers. For olaparib, the company is running concurrent Phase III trials in ovarian, gastric and breast cancers, hoping to win a string of approvals and cobble together a blockbuster.
- read EMA's release (PDF)
- here's AstraZeneca's statement