Phase III trial results needed before PARP inhibitor approved for ovarian cancer indication

One of the two panelists in favor of accelerated approval, Dr. Edward Trimble, director of the Center for Global Health at the National Cancer Institute, Rockville, Md., said that, in his view, the drug had a positive risk-benefit profile. It would be given to a limited number of ovarian cancer patients, was associated with a prolonged disease-free interval in the study, "and protected those patients from going on to intravenous cytotoxic therapy." The availability of an oral maintenance drug would make it possible for patients to avoid having to go to the hospital for chemotherapy for a period of time, which would be "a significant clinical benefit," he added.

SOLO 2 is an international, double-blind placebo-controlled randomized study comparing olaparib to placebo as maintenance therapy in 264* women with platinum-sensitive relapsed ovarian cancer and the gBRCA mutation. The study is evaluating a lower-dose, 300-mg-twice-a-day tablet formulation of olaparib.

The FDA is expected to make a decision by early October. The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts, although occasionally a panelist is given a waiver.

emechcatie@frontlinemednews.com

*CORRECTION, 6/26/2014: An earlier version of this story misstated the number of patients enrolled in the SOLO 2 trial.