Olaparib Approved in Europe for BRCA Ovarian Cancer

Zosia Chustecka

Disclosures

December 18, 2014

The first-in-class drug olaparib (Lynparza, AstraZeneca) has now been granted marketing authorization by the European Commission (EC), following the recommendation for approval that it received in October from the European Medicines Agency. The EC decision is applicable to all 28 European Union member states, as well as Iceland, Liechtenstein, and Norway.

The drug is indicated for use in the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.

A decision on this drug for this indication in the United States is expected early in January 2015, but at the moment, it looks unlikely to be approved there. At a recent meeting of the Oncologic Drugs Advisory Committee of the US Food and Drug Administration, panel members voted 11 to 2 against the approval of olaparib.

Olaparib is the first in a class of drugs that act as inhibitors of poly(ADP)-ribose polymerase (PARP), which exploit tumor DNA repair pathway deficiencies to preferentially kill cancer cells, the company notes.

It is the first PARP inhibitor to be approved for patients with platinum-sensitive relapsed BRCA-mutated ovarian cancer; these patients will be identified through a validated diagnostic test, the company adds.

"This is a devastating disease which has a profound impact on patients and their families. Women with a BRCA mutation are especially at risk and there has been a significant need for new treatment options with novel modes of action," commented John Green, PhD, senior lecturer at the Institute of Translational Medicine, University of Liverpool, and chair of the European Network of Gynaecological Cancer Advocacy Groups (ENGAGe), in a company statement.

The approval of olaparib was based on data from Study 19, a phase 2 clinical trial that evaluated its efficacy and safety, compared with placebo, in platinum-sensitive relapsed high-grade serous ovarian cancer patients (Lancet Oncol. 2014;15:852-861).

The study showed that olaparib maintenance therapy significantly prolonged progression-free survival, compared with placebo, in patients with BRCA-mutated ovarian cancer (median progression-free survival, 11.2 vs 4.3 months; hazard ratio, 0.18; 95% confidence interval, 0.10 - 0.31; P < .0001). The most common adverse events associated with olaparib monotherapy to date were generally mild to moderate and included nausea, vomiting, fatigue, and anemia.

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