SGO Perspective on Olaparib Approval

The U.S. Food and Drug Administration announced Dec. 19 that it has granted accelerated approval to the oral PARP inhibitor, olaparib, in women with recurrent ovarian cancer who carry a germline mutation in the BRCA genes. The announcement establishes a new class of therapy for these patients, and the BRCA analysis test, used for years to identify mutations in the BRCA genes, is the first laboratory-developed test (designed, manufactured and used in a single laboratory) to receive FDA approval as a companion diagnostic test for therapy. Olaparib’s approval was based on an observed objective response rate of 34 percent in 137 germline carriers who had received 3 or more lines of prior chemotherapy. The median duration of response was nearly 8 months and no new safety signals emerged from this dataset. Usage under the new label will be limited to women with ovarian cancer who have a BRCA mutation as identified by the BRCA analysis test and in whom 3 or more lines of chemotherapy have been administered. In June 2014, FDA’s Oncologic Drugs Advisory Committee (ODAC) reviewed olaparib for the indication of maintenance therapy following response to platinum-based chemotherapy for recurrent ovarian cancer. Citing concerns in study conduct and potential long term toxicities, ODAC voted not to recommend olaparib for accelerated approval in that indication. However, data supplied to FDA shortly after the ODAC opinion was convincing in meeting their benchmark of a therapeutic producing an effect on a surrogate endpoint likely to produce a clinical benefit. Results from ongoing and completed clinical trials will be evaluated for safety and efficacy before full approval is granted.


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