June 23 Staff reviewers at the U.S. Food and
Drug Administration said AstraZeneca Plc's experimental
ovarian cancer drug olaparib showed an 83 percent reduction in
the risk of disease progression but questioned whether the
result could be reproduced.
The drug, olaparib, is designed as a maintenance treatment
for certain women with relapsed ovarian cancer whose tumors are
responding completely or in part to platinum-based chemotherapy.
Olaparib blocks the activity of Poly (ADP-ribose) polymerase
(PARP), an enzyme that plays a key role in cell repair. The drug
is aimed at women with a BRCA gene mutation. Patients in a
clinical trial had a seven-month median improvement in
The staff report, published on the FDA's website on Monday,
comes two days ahead of a meeting of outside experts who will
discuss whether the drug's benefits outweigh its risks and
whether further data is needed before approval.
(Reporting by Toni Clarke in Washington; Editing by Bill Trott)