AstraZeneca has suffered a setback with advisors to the US Food and Drug Administration recommending against accelerated approval of olaparib for ovarian cancer.
The agency’s Oncologic Drugs Advisory Committee has voted 11 to 2 that current evidence does not support early approval for use of olaparib as a maintenance treatment for platinum-sensitive relapsed ovarian cancer in women who have the germline BRCA mutation, and who are in complete or partial response to platinum-based chemotherapy. The vote comes after FDA staffers expressed concern about a subgroup retrospective analysis of Phase II data on the poly ADP-ribose polymerase (PARP) inhibitor which revealed a 7.1 month median improvement in progression-free survival.
AstraZeneca decided, in December 2011, not to progress olaparib into Phase III, but reversed that decision on the basis of results for the aforementioned subgroup. It received priority review status in April from the FDA but the latter’s staffers have questioned whether the reanalysis skewed the results.
The panel also mentioned safety issues such as bone marrow suppression, fatigue, nausea and abdominal pain and cases of myelodysplastic syndrome and acute myeloid leukaemia in study participants that had a small risk of being linked to olaparib.
Read more at: http://www.pharmatimes.com/Article/14-06-26/FDA_panel_fails_to_back_AZ_ovarian_cancer_drug_olaparib.aspx#ixzz35oFFDLgE
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