On August 17, 2017, the FDA approved a new indication for olaparib (Lynparza; AstraZeneca Pharmaceuticals), in tablet form, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease completely or partially responded to chemotherapy that was platinum-based, regardless of their BRCA mutation status.
Olaparib was first approved in 2014 as a capsule for the treatment of patients with toxic or suspected deleterious germline BRCA-mutated advanced ovarian cancer who had received ≥3 chemotherapy lines. Olaparib tablets and capsules are not interchangeable, and the capsules, which are being phased out, will eventually only be accessible through the Lynparza Specialty Pharmacy Network.
“Today’s approval is welcome news for US patients with ovarian cancer, who are now able to benefit from treatment with olaparib irrespective of their BRCA mutation status. This latest regulatory milestone underscores the breadth and depth of clinical data on olaparib, and not only demonstrates its efficacy as maintenance therapy, but adds to the data presented earlier this year showing sustained quality of life for patients undergoing treatment for this serious disease,” said Eric Pujade-Lauraine, MD, PhD, Head of the Women’s Cancers and Clinical Research Department at Hôpitaux Universitaires Paris Centre, France, and Principal Investigator of the SOLO-2 clinical trial, in a press statement released by AstraZeneca Pharmaceuticals.
The approval of olaparib tablets was based on data from 2 randomized, placebo-controlled, double-blind, multicenter clinical trials of patients with recurrent ovarian cancers whose disease had responded to platinum-based chemotherapy.
Among 295 patients in the SOLO-2 trial, investigators reported that progression-free survival (PFS) improved significantly in those randomized to receive olaparib tablets compared with those receiving placebo. The estimated median PFS was 19.1 months in the olaparib arm versus 5.5 months in the placebo arm.
Investigators in the Study 19 trial reported that, among the 265 patients randomized to receive olaparib capsules or placebo, a significant improvement was seen in the PFS of the olaparib arm compared with the placebo arm. The estimated median PFS was 8.4 months for patients who received olaparib versus 4.8 months for those who received placebo. In addition, patients treated with olaparib as maintenance therapy had a median overall survival of 29.8 months compared with 27.8 months for those who received placebo.
The most common (≥20%) adverse reactions reported in patients who received olaparib were anemia, nausea, fatigue, vomiting, nasopharyngitis, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, and stomatitis. The most common (≥25%) laboratory abnormalities reported were decreased hemoglobin, increased mean corpuscular volume, reduced lymphocytes, decreased leukocytes, decreased absolute neutrophil count, increased serum creatinine, and decreased platelets.