FDA
27th June 2014

FDA Committee Votes Against Accelerated Approval of Olaparib

There was one voting and one discussion question during this meeting. The panelists voted 11 to 2 against early approval when asked whether the safety and efficacy results from Study 19 in the gBRCAm population support an accelerated approval.

FDA Committee Votes Against Accelerated Approval of Olaparib

During this meeting, the Oncologic Drugs Advisory Committee discussed new drug application (NDA) 206162, olaparib capsules, submitted by AstraZeneca Pharmaceuticals LP. The proposed indication for this product is as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal) with germline BRCA mutation as detected by an FDA-approved test, who are in response (complete response or partial response) to platinum-based chemotherapy. 

There was one voting and one discussion question during this meeting. The panelists voted 11 to 2 against early approval when asked whether the safety and efficacy results from Study 19 in the gBRCAm population support an accelerated approval.

FDA cancer chief Richard Pazdur noted that, “This trial has problems.” If investigators had “pristine evidence of a 7-month advantage in PFS, we wouldn’t be here.” It was the panel’s job to consider if there were other clinical benefits that warrant an early approval for this drug as a maintenance therapy.

Study 19 demonstrated positive results in terms of an 83% reduction in the risk of progression or death and a seven-month median improvement in PFS (progression-free survival) for patients with platinum-sensitive, gBRCAm-associated ovarian cancer in the maintenance setting.

The panelists voiced their concerns about the results of Study 19, noting that there were too many troubling questions about potential risks of the drug such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). In addition, the panel noted other uncertainties related to the validity and reproducibility of the magnitude of effect and the scarceness of actual efficacy data that demonstrated an improvement on progression-free survival. 

Panelists widely agreed that approval should be delayed until at least the results of SOLO-2 became available. SOLO-2 is a phase III confirmatory study designed to evaluate the efficacy and safety of olaparib as a maintenance monotherapy in ovarian cancer patients with a BRCA mutation (who are in complete or partial response following platinum-based chemotherapy in the relapsed setting). 

The FDA is not obligated to follow the decision of its committees, although it usually does.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

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