AstraZeneca Takes Impairment Charge After Olaparib, TC-5214 Setbacks
This article was originally published in The Pink Sheet Daily
Olaparib and TC-5214 development setbacks at AstraZeneca lead to $380 million charge in the fourth quarter, with core EPS likely at the bottom of the expected range.
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Oncologic Drugs Advisory Committee will consider whether the first-in-class PARP inhibitor should come to market on the basis of Phase II data in a subgroup of patients or await results from an ongoing confirmatory study. Agency cites “uncertainties” about validity and magnitude of effect seen in the Phase II trial.
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.