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FDA Approves Lynparza for Ovarian Cancer
FDA news release; 2017 Aug 17
The FDA has approved Lynparza (olaparib) for the maintenance treatment of patients with ovarian cancer.
Indications: Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
Dosage and administration: 300 mg taken orally twice daily with or without food.
Efficacy and safety: Approval is based on results of 2 randomized, placebo-controlled, double-blind, multicenter trials which demonstrated statistically significant improvement in progression-free survival in patients receiving Lynparza, vs those treated with placebo.
Side effects/risks: The most common adverse reactions are anemia, nausea, fatigue, vomiting, nasopharyngitis/upper respiratory tract infection/influenza, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, and stomatitis.
FDA approves olaparib tablets for maintenance treatment in ovarian cancer [news release]. Silver Spring, MD: FDA. August 17, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm572143.htm. Accessed August 27, 2017.
Lynparza [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208558s000lbl.pdf. Accessed August 27, 2017.
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