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Maintenance Olaparib Data Published as FDA Weighs Approval

Jason Harris
Published: Tuesday, Aug 01, 2017

Dr. Eric Pujade-Lauraine

Eric Pujade-Lauraine, MD, PhD
Maintenance olaparib (Lynparza) reduced the risk of risk of progression or death by 70% compared with placebo for patients with platinum-sensitive, relapsed, BRCA-mutant ovarian cancer, according to results from the phase III SOLO2/ENGOT Ov-21 trial published in The Lancet Oncology.

Four patients in the both groups experienced acute myeloid leukemia, myelodysplastic syndrome, and/or chronic myelomonocytic leukemia during the study and long-term follow-up. Overall, the incidence of all secondary malignancies during the study and long-term follow-up was 6 patients (3%) in the olaparib group and 5 patients (5%) in the placebo group.
Pujade-Lauraine E, Ledermann JA, Selle F, et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial [published online July 25]. Lancet Oncol. doi: 10.1016/S1470-2045(17)30469-2.

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