AstraZeneca Mulls Broad Ovarian Cancer Maintenance Approval For Lynparza
Tesaro's niraparib has an advantage over other PARP inhibitors in that it has been tested successfully in Phase III for ovarian cancer patients with and without BRCA mutations, but AstraZeneca thinks it may have a case for broad labeling without pivotal data in this population.
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Keeping Track: Oncology Stays Hot With Besponsa And Lynparza Approvals; New Uses Of Adcetris, Cabometyx Submitted
The latest drug development news and highlights from our US FDA Performance Tracker.
AstraZeneca's Lynparza now has the broadest US label of all PARP inhibitors for ovarian cancer, as well as competitive dosing, posing a threat to Tesaro's reigning Zejula.
The OlympiAD monotherapy study paves the way for AstraZeneca's Lynparza in breast cancer, as well as other PARP inhibitors down the line, but the ASCO presentation raises questions about trial design and whether combinations are needed to boost efficacy.