(Curetoday.com) Nov 12, 2018 - The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for Lynparza (olaparib) 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. The sNDA is based on data from the phase 3 SOLO-1 trial, in which the PARP inhibitor Lynparza significantly improved progression-free survival (PFS) as frontline maintenance for this patient population. With a median follow-up of 41 months, the median PFS by independent central review was not reached in the Lynparza arm (260 patients), versus 14.1 months in the placebo arm (131 patients). The investigator-assessed PFS in the Lynparza arm was not reached, compared to 13.8 months in the placebo arm.
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