AstraZeneca's (AZN) - Get Report Lynparza significantly delayed the recurrence of tumors in patients with ovarian cancer compared to a placebo, according to results from a phase III study announced by the company Wednesday.
Lynparza belongs to a closely followed class of cancer drugs known as PARP inhibitors. Wednesday's positive study results, if confirmed, position Lynparza for expanded U.S. approval as a maintenance therapy in ovarian cancer.
AstraZeneca is withholding specific data from the Lynparza ovarian cancer maintenance therapy study, so making comparisons to Tesaro's niraparib isn't possible quite yet.
What we do know, thanks to AstraZeneca's limited disclosure Wednesday, is that Lynparza "substantially exceeded" results seen in a previously conducted phase II maintenance study.
In that phase II study, which enrolled ovarian cancer patients with mutation to a tumor suppressor gene known as BRCA, treatment with Lynparza demonstrated an 82% reduction in the risk of tumor progression compared to placebo. At the median, Lynparza progression-free survival was 11.2 months compared to 4.3 months for placebo.
Lynparza is already approved in the U.S. as a treatment for ovarian cancer patients with BRCA mutant tumors no longer responsive to three or more prior therapies. In Europe, Lynparza is approved as a second-line maintenance therapy for ovarian cancer patients with BRCA mutated tumors.
AstraZeneca's plan is to expand Lynparza's marketing label in the U.S. to include maintenance therapy for ovarian cancer, a larger commercial opportunity, based on the data from the phase III study announced Wednesday.
Racing AstraZeneca to the FDA will be Tesaro, which is expected to file a new drug application before the end of the year for niraparib as a maintenance therapy for ovarian cancer.
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