BioCentury
ARTICLE | Clinical News

Olaparib regulatory update

June 30, 2014 7:00 AM UTC

FDA’s Oncologic Drugs Advisory Committee voted 11-2 that safety and efficacy data do not support accelerated approval of olaparib from AstraZeneca and that the agency should delay considering approval until results are available from the ongoing confirmatory Phase III SOLO2 trial. AZ is seeking accelerated approval of the poly(ADP-ribose) polymerase (PARP) inhibitor as maintenance treatment of platinum-sensitive relapsed ovarian cancer in patients with germline breast cancer early onset (BRCA) mutations who are responding to platinum-based chemotherapy. The PDUFA date is Oct. 3. SOLO2 is expected to complete enrollment in early 2015, with data expected by the end of 2015.

AZ’s application is based on a Phase II trial (Study 19), in which that subgroup of patients showed a 7.1-month progression-free survival (PFS) benefit with olaparib vs. placebo. ODAC panelists were concerned this difference was unreliable because it came from a small set of patients whose BRCA mutations were identified retrospectively, which both FDA and panelists said may have compromised randomization. Panelists also said olaparib’s side effects, including a risk of myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML), might offset the potential benefits of increased PFS. ...