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FDA Questions the Efficacy of Astra's PARP Inhibitor in Ovarian Cancer Treatment
The FDA staff report questioned the unusually poor performance of the control group used in the study.
AstraZeneca Plc's experimental ovarian cancer drug, olaparib, showed an 83 percent reduction in the risk of disease progression, but a U.S. Food and Drug Administration staff review has questioned whether the result could be reproduced.
The company's shares fell 1.8 percent to 43.89 pounds on the London Stock Exchange.
Olaparib, one of several cancer drugs AstraZeneca has flagged as having strong potential in its defense of a $118 billion take-over bid by , is designed as a maintenance therapy for relapsed ovarian cancer in which tumors have responded completely or partially to platinum-based chemotherapy.
"AstraZeneca has put up some pretty lofty expectations," said Damien Conover, an analyst at Morningstar.
The FDA staff report, published on the agency's website on Monday, comes two days ahead of a meeting of outside experts who will discuss whether olaparib's benefits outweigh its risks and whether further data is needed before approval.
The FDA is not obligated to follow the recommendations of its advisory panels but typically does so.
Original report:
Source: Reuters
Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
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Texas Oncology to Roll Out Canopy for ePROs After Head-to-Head Pilot
March 18th 2025Debra Patt, MD, PhD, MBA, executive vice president of Public Policy and Strategy for Texas Oncology, said the practice received positive feedback from nurses and patients during a pilot that concluded in February.
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Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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