FDA Approval Alert: Maintenance Therapy for Trio of Cancers


The US Food and Drug Administration (FDA) has granted regular approval to a treatment indicated for maintenance therapy in adult patients with any of three malignancies.


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Olaparib (Lynparza, AstraZeneca) tablets were approved today for the 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. Olaparib capsules were approved in 2014 for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with at least three lines of prior chemotherapy. However, the capsules are being phased out of the United States market.

Today’s approval came following results of two randomized, placebo-controlled, double-blind, multicenter trials. In SOLO-2, a total of 295 patients with recurrent germline BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer who were randomized to receive olaparib tablets (300 mg orally, twice daily) or placebo demonstrated improved progression-free survival (PFS) in the olaparib arm (19.1 months vs 5.5 months, respectively). In study 19, a total of 265 patients were randomized regardless of BRCA status to receive olaparib or placebo. Estimated median PFS was 8.4 months and 4.8 months, respectively.

Adverse events associated with olaparib include anemia, nausea, fatigue, vomiting, nasopharyngitis, diarrhea, arthralgia or myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, and stomatitis.

Recommended dosage for both the maintenance therapy and later-line treatment setting is 300 mg (150 mg tablets, twice daily) with or without food.—Zachary Bessette