Ovarian cancer drug receives accelerated approval

An ADP-ribose polymerase (PARP) inhibitor has received accelerated approval from the US Food and Drug Administration (FDA) for treatment of women with heavily pretreated ovarian cancer associated with defective BRCA genes. The action on Lynparza (olaparib) was in conjunction with approval of BRACAnalysis CDx, a companion diagnostic for detection of BRCA mutations (gBRCAm) in patients with ovarian cancer.

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Lynparza’s efficacy was studied in 137 women with gBRCAm-associated ovarian cancer, based on measurement of objective response rate (ORR). The results indicated that 34% of the women experienced ORR for an average of 7.9 months.

Common side effects included indigestion, fatigue, decreased appetite, back pain, rash, and cough. Serious side effects were noted including acute myeloid leukemia, lung inflammation, and myelodysplastic syndrome.

The BRACAnalysis CDx test was reviewed under the FDA’s priority review program for devices. It had previously been marketed by the manufacturer as a laboratory-developed test for use in a single laboratory. Blood samples from participants in the study of Lynparza were used to validate detection of BRCA mutations in that population.

Of the approval, Richard Pazdur, director of the Office of Hematology and Oncology Products in the 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.”

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