AstraZeneca's Lynparza tablets substantially delayed the recurrence of ovarian cancer in women compared with a placebo, according to results of a Phase 3 patient study announced Wednesday.
The United Kingdom-based drugmaker, with North American headquarters in Wilmington, said it was "working with regulatory authorities, including the Food and Drug Administration, to make Lynparza tablets available as quickly as possible to patients with ovarian cancer."
Lynparza, whose generic name is olaparib, already is approved in the United States as a treatment for patients with BRCA-mutated metastatic ovarian cancer who have been treated with three or more prior chemotherapy medicines. AstraZeneca wants to expand the marketing label to include Lynparza as a maintenance therapy for ovarian cancer. Earlier this year, the FDA granted a "fast-track designation" for the drug, which is in a class known as PARP inhibitors.
Lynparza is being studied as a single therapy, and in combination with other treatments, for a "range of tumor types" including ovarian, breast, pancreatic, and prostate cancer, the company said.
AstraZeneca did not release specific study data for the patients who have "platinum-sensitive, relapsed BRCA-mutated ovarian cancer." It said the results showed "a clinically meaningful and statistically significant improvement in progression-free survival" compared with a placebo.
Another drugmaker, Tesaro, has a rival medicine, niraparib, which it said in June slowed the growth of ovarian tumors. Tesaro said it plans to file for regulatory approval for its ovarian-cancer therapy in the U.S. and Europe before the end of this year.