FROM THE FDA

Olaparib, a poly ADP-ribose polymerase (PARP) inhibitor, has been approved for treating advanced ovarian cancer associated with defective BRCA genes, the Food and Drug Administration announced on Dec. 19.

Olaparib “is the first of a new class of drugs for treating ovarian cancer,” Dr. Richard Pazdur, director of the office of hematology and oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement announcing approval. Olaparib “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,” he added.

Olaparib will be marketed as Lynparza, by Astra Zeneca Pharmaceuticals. It was approved with a companion diagnostic test for BRCA gene mutations, the BRCA test – the BRACAnalysis CDx – is manufactured by Myriad Genetic Laboratories, which will also perform the tests.

The recommended dose is 400 mg taken twice a day, continued until the disease progresses or toxicity becomes unacceptable.

The specific approved indication is as monotherapy “in patients with deleterious or suspected deleterious germline BRCA mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy,” according to the prescribing information . The prescribing information also includes the statement that this is an accelerated approval, which is based on the objective response rate and duration of response, and “continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.”

The use of olaparib as maintenance therapy for ovarian cancer was reviewed at a meeting of an FDA advisory panel meeting in June, where most of the panel voted that the data did not support accelerated approval for this indication. After that meeting, AstraZeneca submitted data supportive of the indication that has been approved, according to the FDA statement.

In a study of 137 women with gBRCAm-associated ovarian cancer who were treated with olaparib, 34% had an objective response rate for an average of 7.9 months, according to the FDA.

Common adverse events associated with treatment included nausea, fatigue, vomiting, diarrhea, dysgeusia, headache, myalgia, and dermatitis, according to the FDA. Serious adverse events included myelodysplastic syndrome, acute myeloid leukemia, and pneumonitis.

emechcatie@frontlinemedcom.com

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