FDA Approves Lynparza (Olaparib) for Some Ovarian Cancers

The US Food and Drug Administration (FDA) approved Lynparza (olaparib) for women with advanced ovarian cancer caused by a mutated BRCA gene, and who have already had several other treatments. It’s the first drug of its kind, a PARP inhibitor, to be approved in the US. The FDA also approved a test called BRACAnalysis specifically to identify women who may be candidates for treatment with Lynparza.

PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. In certain tumor cells, such as those from BRCA mutation carriers, blocking this enzyme can lead to cell death. Women who carry BRCA mutations are at a higher risk of developing some types of cancer, including ovarian and breast cancers.

The FDA approved Lynparza under its accelerated approval program for drugs that show promise against a serious disease. It based its approval of both Lynparza and BRACAnalysis on a clinical trial that involved 137 women with ovarian cancer linked to a BRCA gene mutation. All the women received Lynparza. More than a third (34%) of them experienced partial shrinkage or complete disappearance of the tumor, for an average of 7.9 months.

The approval was unexpected because earlier this year, an FDA advisory committee voted against the accelerated approval of Lynparza. But the committee had considered a different use of the drug – as a therapy to help prevent ovarian cancer recurrence. After that, the manufacturer submitted additional data supporting the use of Lynparza for women with ovarian cancer caused by a BRCA mutation, and who had already received 3 or more chemotherapy treatments.

Common side effects of Lynparza include nausea and vomiting, fatigue, diarrhea, indigestion, headache, appetite problems, common cold-like symptoms, cough, rash, and pain in joints, muscles, bones, back, and abdomen.

Serious side effects can include the development of a bone marrow disorder, acute myeloid leukemia (a bone marrow cancer), and lung inflammation.

Lynparza is marketed by AstraZeneca Pharmaceuticals and BRACAnalysis is manufactured by Myriad Genetic Laboratories, Inc.

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