FDA Grants Regular Approval for Ovarian Cancer Treatment
The US Food and Drug Administration (FDA) has granted regular approval to olaparib tablets (Lynparza) for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
In 2014, the FDA approved olaparib capsules for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Olaparib tablets are approved for this indication but are not interchangeable with the capsules—the capsules are being phased out of the US market.
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_________________________________________________________________________________________________________________________________________________Olaparib tablets as both maintenance therapy or later-line treatment are recommended to be administered orally at 150 mg twice daily, with a combined daily dose of 300 mg, and can be taken with or without food.
Common adverse events associated with olaparib treatment included anemia, nausea, and fatigue (including asthenia).
FDA approves olaparib tablets for maintenance treatment in ovarian cancer [press release]. Silver Spring, MD: US Food and Drug Administration; August 17, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm572143.htm. Accessed August 17, 2017.