The PARP inhibitor olaparib has been granted FDA approval for the following:
* New use of olaparib tablets as a maintenance treatment of adult patients with recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status
* New use of olaparib tablets (two tablets twice daily) as opposed to capsules (eight capsules twice daily)
* Olaparib tablets are also now indicated for the use in adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCA) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy; patients for this indication are selected for therapy based on an FDA-approved companion diagnostic.
Two randomized trials supported the new approvals and the conversion of accelerated approval to full approval, which was originally based on a single-arm trial:
* SOLO-2 (n=295) confirmed the benefit of olaparib in gBRCA-mutated patients, demonstrating a 70 percent reduced risk of disease progression or death (HR 0.30 [95% CI, 0.22-0.41], P<0.0001) and improved median progression-free survival (PFS) to 19.1 months versus 5.5 months for placebo by investigator-assessed analysis.
* Study 19 (n=265) showed that olaparib reduced the risk of disease progression or death by 65 percent and improved PFS compared with placebo in patients of any BRCA status (HR 0.35 [95% CI, 0.25-0.49], P<0.0001; median PFS of 8.4 months with olaparib vs. 4.8 months with placebo). Additionally, patients in Study 19, treated with olaparib as a maintenance therapy had a median overall survival of 29.8 months versus 27.8 months for placebo (HR 0.73 [95% CI, 0.55-0.95]).
Richard Penson, MD, Clinical Director of Medical Gynecologic Oncology at Massachusetts General Hospital Cancer Center, Associate Professor of Medicine at Harvard Medical School, and the primary investigator in the SOLO-2 trial, noted: "Today's approval demonstrates that olaparib is an effective option for maintenance therapy for certain ovarian cancer patients, regardless of BRCA status. We welcome this news in the ovarian cancer community as more options are important to help us ensure that patients can find a treatment that is right for them."