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FDA Grants Olaparib Priority Review for Frontline Maintenance in Ovarian Cancer

Jason M. Broderick and Angelica Welch
Published: Monday, Nov 12, 2018

The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for olaparib (Lynparza) tablets for use as a maintenance therapy in patients with newly-diagnosed, BRCA-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy.

 mutation previously treated with 3 or more lines of chemotherapy.
Moore K, Colombo N, Scambia G, et al. Olaparib maintenance therapy following first-line platinum-based chemotherapy in patients with FIGO stage III–IV ovarian cancer (OC) with a BRCA1/2 mutation (BRCAm): Phase III SOLO1 trial. In: Proceedings from the 2018 ESMO Congress; October 19-23, 2018; Munich, Germany. Abstract LBA7_PR

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