Ovarian Cancer Drugs Will Get ICER Review As Olaparib's Maintenance Indication Looms
PARP inhibitors from Tesaro, Clovis, and AstraZeneca have been tentatively chosen for the evaluation.
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With new branded immunotherapy-based double- or triple-drug combinations on the way, there is greater scrutiny of costs and efficiency.
FDA granted accelerated approval to PARP inhibitor Rubraca for treatment with BRCA-mutation positive ovarian cancer patients treated with two or more chemotherapies.
AstraZeneca hopes "robust" data from its Phase III SOLO-2 trial will pave the way for its PARP-inhibitor Lynparza (olaparib) to be used in the US market as a maintenance therapy in BRCA-mutated second-line ovarian cancer. But some analysts think FDA may want more proof before giving the okay.