The U.S. Food and Drug Administration (FDA) has approved olaparib tablets (Lynparza) as a maintenance treatment for adult patients experiencing recurrent epithelial ovarian fallopian tube, or primary peritoneal cancer, who are in response (either complete or partial) to platinum-based chemotherapy.
The approval, based on 2 randomized, placebo-controlled, double-blind, multicenter trials, is not dependent on a patient’s BRCA
status. The primary outcome measure in both trials was progression free survival (PFS).
In ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer, malignant cancer cells form in the tissue covering the ovary or lining the fallopian tube or peritoneum.
In the Phase 3 SOLO2 trial
, 295 patients who had responded to chemotherapy for recurrent germline BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer were randomized to receive either olaparib tablets (300 mg) orally twice a day, or placebo. The study demonstrated a statistically-substantial enhancement in investigator-assessed PFS in patients randomized to olaparib in comparison to recipients of placebo.
The estimated median PFS was 19.1 months in the olaparib arm, and 5.5 months in the placebo arms.
In Study 19
, 265 patients who had responded to chemotherapy, regardless of BRCA
status, received either olaparib capsules (400 mg) orally twice each day, or placebo. The study showed a statistically significant improvement in investigator-assessed PFS in patients treated with olaparib compared to placebo.
The estimated median PFS was 8.4 months and 4.8 months in the olaparib and placebo arms, respectively.
Across both studies, common adverse events (AE) included anemia, fatigue, nausea, vomiting, diarrhea, nasopharyngitis, dysgeusia, stomatitis, headache, decreased appetite, arthralgia/myalgia, and constipation.
It is recommended that the olaparib tablet dose for both the maintenance therapy and later line treatment setting is 300 mg (two 150 mg tablets) taken orally twice daily.
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