Lynparza approved to treat advanced ovarian cancer

December 19, 2014

FDA has approved olaparib (Lynparza, AstraZeneca) for the treatment of women with advanced ovarian cancer associated with defective BRCA genes, as determined by an FDA-approved test.

FDA has approved olaparib (Lynparza, AstraZeneca) for the treatment of women with advanced ovarian cancer associated with defective BRCA genes, as determined by an FDA-approved test.

FDA approved Lynparza with a genetic test called BRACAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with ovarian cancer. The BRCA genes are involved with repairing damaged DNA and normally work to suppress tumor growth. Women with mutations resulting in defective BRCA genes are more likely to get ovarian cancer, and it is estimated that 10% to 15% of all ovarian cancer is associated with these hereditary BRCA mutations.

Ovarian cancer ­accounts for about 3% of cancers among women, but it causes more deaths than any other cancers of the female reproductive system. The National Cancer Institute estimates that more than 21,000 American women will be diagnosed with and over 14,000 will die from ovarian cancer in 2014.

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Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that acts by blocking the enzymes involved in the repair of damaged DNA, which ultimately causes cancer cell death.

Lynparza is indicated for the treatment of ovarian cancer patients with mutations in the BRCA genes, which are involved in repairing damaged DNA and normally work to suppress tumor growth. Women with these mutations are more likely to get ovarian cancer. The drug is approved with the use of BRACAnalysis, a genetic test used to detect the presence of the BRCA mutations in a patient’s blood sample. Lynparza is indicated for treatment in patients who have been treated with three or more prior lines of chemotherapy.

In an FDA press release, Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said: “Today’s approval constitutes the first of a new class of drugs for treating ovarian cancer. Lynparza is approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment."

FDA approved Lynparza under its accelerated approval program.

The approval of Lynparza was based on a clinical trial conducted to determine the efficacy of the drug. The study included 137 participants with gBRCAm-associated ovarian cancer and was designed to measure the percentage of participants who experienced partial shrinkage or complete disappearance of the tumor. Results showed that 34% of patients responded for an average of 7.9 months. Common side effects associated with the use of Lynparza included nausea, fatigue, vomiting, and diarrhea.

Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.