The FDA today granted regular approval to olaparib tablets for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who achieved complete or partial response to platinum-based chemotherapy.
The approval of olaparib (Lynparza, AstraZeneca) — a poly ADP ribose polymerase (PARP) inhibitor — coincides with the introduction of a tablet formulation.
The tablets are approved for the new maintenance therapy indication, as well as for treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who underwent three prior lines of chemotherapy.
Olaparib capsules have been FDA approved for the latter indication since 2014. However, the capsules are being phased out of the U.S. market, and the tablet and capsule formulations are not interchangeable, according to an FDA-issued press release.
The FDA based the maintenance therapy approval on results of two randomized, placebo-controlled, double-blind trials.
The SOLO-2 trial included 295 women with recurrent germline BRCA-positive ovarian, fallopian tube or primary peritoneal cancer.
Researchers assigned patients 2:1 to olaparib tablets 300 mg twice daily or placebo. Olaparib-treated patients achieved significantly longer investigator-assessed PFS (median, 19.1 months vs. 5.5 months; HR = 0.3; 95% CI, 0.22-0.41).
Study 19 included 265 women enrolled regardless of BRCA status. Researchers assigned women 1:1 to olaparib capsules 400 mg orally twice daily or placebo. Olaparib-treated patients achieved significantly longer investigator-assessed PFS (median, 8.4 months vs. 4.8 months; HR = 0.35; 95% CI, 0.25-0.49).
The most common adverse reactions included anemia, nausea, fatigue, vomiting, nasopharyngitis, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation and stomatitis.
The most common laboratory abnormalities included decreases in hemoglobin, lymphocytes, leukocytes, absolute neutrophil count and platelets, and increases in mean corpuscular volume and serum creatinine.