August 17, 2017—Today, the U.S. Food & Drug Administration granted regular approval to a new olaparib formulation for the maintenance treatment of adults patients experiencing recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are currently in a complete or partial response to platinum-based chemotherapy. With this expanded approval, a new tablet formulation of olaparib is available, following its capsule formulation originally approved in December 2014.
This approval is based on the results of the phase 3 SOLO-2 (NCT01874353) and phase 2 Study 19 (NCT00753545) trials.
In SOLO-2, 295 patients with recurrent germline BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer were randomized (2:1) to receive olaparib tablets 300 mg orally twice daily or a placebo. Presented at the 48th Annual Meeting of the Society of Gynecologic Oncology, SOLO-2 demonstrated a statistically significant improvement in progression-free survival (PFS). The estimated median PFS was 19.1 versus 5.5 months in patients receiving olaparib and placebo, respectively. Overall survival data was immature at this time.
In Study 19, 265 patients with platinum-sensitive, recurrent high-grade serous ovarian cancer, regardless of BRCA status, were randomized (1:1) to receiving olaparib capsules 400 mg twice daily or a placebo. Presented at the 2016 ASCO Annual Meeting, Study 19 also demonstrated a statistically significant improvement in PFS. The estimated median PFS was 8.4 months versus 4.8 months in patients receiving olaparib and placebo, respectively.
In both trials, the most common adverse events included anemia, nausea, fatigue, vomiting, diarrhea, headache, dyspepsia, decreased appetite, constipation, etc. Please visit the FDA’s website for more information on this approval.
Published Online: Thursday August 17, 2017