FDA clears Tesaro's PARP inhibitor Zejula for recurrent ovarian cancer

Tesaro on Monday announced that the FDA approved Zejula (niraparib) for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Tesaro, which plans to launch the therapy in the US late next month, noted that the drug is the first FDA-approved PARP inhibitor that does not require BRCA mutation or other biomarker testing. 

The approval was backed by data from the Phase III ENGOT-OV16/NOVA trial including 553 patients with recurrent ovarian cancer who exhibited a complete or partial response to their most recent platinum-based chemotherapy. Study results, which were unveiled last October, showed that the therapy was associated with reductions in the risks of death or disease progression irrespective of germline BRCA status, with the magnitude of the benefit being similar in patients with complete or partial responses. 

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"Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment," commented Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncology Center of Excellence, adding "Zejula offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation." 

Zejula has been awarded fast track, priority review and orphan drug designation by the FDA for the treatment of recurrent ovarian cancer, while the therapy also remains under review in Europe for the same indication. Meanwhile, Johnson & Johnson acquired exclusive global rights to the drug for the treatment of prostate cancer last year.

For additional analysis on the PARP inhibitor class, see ViewPoints: AstraZeneca turns the screw in PARP inhibitor race. See also Spotlight On: Should Big Pharma be doing a better job when discarding its 'failed' drugs? 

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