AstraZeneca Back In The PARP Mix With Olaparib In Ovarian Cancer
This article was originally published in Pharmaceutical Approvals Monthly
Olaparib is off the shelf and into a Phase III trial against ovarian cancer in platinum-sensitive BRCA-positive patients, adding to the list of late-stage PARP inhibitors vying for first-in-class status.
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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.
Myriad president Mark Capone made it clear that the company will use its proprietary database of genetic variants on the BRCA1 and BRCA2 genes to try and fend off cheaper competition after the BRACAnalysis test’s method patents are expired, or if they are overturned in court.
Tesaro Inc. announced the launch of a Phase III trial for its PARP inhibitor niraparib in ovarian cancer, while registrational data from three global Phase III studies for anti-emetic rolapitant are due by the end of 2013.