Myriad's Ovarian Cancer Test Proves Its Mettle as Tesaro Companion Dx
Myriad’s myChoice HRD test has demonstrated its ability to identify more than twice as many ovarian cancer patients who may benefit from treatment with Tesaro’s drug investigational drug niraparib, compared with patient stratification by germline-BRCA testing alone.
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Keeping Track: Novartis' Ribociclib, Tesaro's Niraparib Submitted; Catalyst Clears Path For Firdapse Resubmission
In retrospect, the European Society for Medical Oncology meeting was a showcase for pivotal trial data included in a burst of targeted therapy new drug applications, and more drug development news and highlights from our FDA Performance Tracker.
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.
Positive Phase III data for Tesaro's PARP inhibitor, niraparib, have edged the drug ahead of its pipeline competitors and set the company up to give AstraZeneca's marketed therapy, Lynparza, a run for its money – but will modest PFS results be enough to convince regulators to grant a broader ovarian cancer approval for niraparib?