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Smarting from Avastin in breast cancer, ODAC snubs AZ's olaparib in ovarian
Applying Avastin's lessons
Monday, June 30, 2014
With the memory of the 2011 withdrawal of Avastin
bevacizumab in breast cancer still fresh in their minds, members of FDA's Oncologic Drugs Advisory Committee
recommended against accelerated approval for olaparib from AstraZeneca plc
for ovarian cancer. Concerns about the validity and clinical significance of
the PFS data led the panel to conclude it could not put the therapy's risks in
On June 25,
ODAC voted 11-2 against recommending accelerated approval of olaparib as a
maintenance therapy for women with platinum-sensitive ovarian cancer.
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