AstraZeneca's Olaparib Fails to Impress FDA Panel - Analyst Blog


AstraZeneca ( AZN ) announced that the FDA's Oncologic Drugs Advisory Committee (ODAC) voted against (11-2) accelerated approval of its oncology candidate, olaparib. The company is looking to get olaparib approved as a maintenance treatment for patients suffering from platinum-sensitive relapsed ovarian cancer with the germline BRCA mutation, and who are in complete or partial response to platinum-based chemotherapy.

We remind investors that the FDA had granted priority review status for olaparib's marketing application in Apr 2014. . The regulatory agency is expected to render a final decision by Oct 3, 2014. We note that the FDA is not bound to accept the recommendation of the ODAC panel, but it generally does so while deciding on the fate of a drug.

AstraZeneca had submitted the marketing application for olaparib in Feb 2014 based on a subgroup analysis of data from a phase II study. The randomized, double-blind, placebo-controlled study compared the use of olaparib and placebo as maintenance treatment in platinum-sensitive relapsed serous ovarian cancer patients who had received previous treatment with at least two platinum regimens and were in a maintained partial or complete response following their last platinum regimen. The study met the primary endpoint of progression-free survival.

Meanwhile, the company plans to continue to evaluate olaparib in a phase III study in patients with relapsed BRCA-mutated ovarian cancer. Data from the study is expected to mature by the end of 2015. AstraZeneca has also initiated a phase III SOLO program to evaluate the efficacy and safety of olaparib as a maintenance monotherapy in BRCA-mutated ovarian cancer patients, who are in complete or partial response following platinum-based chemotherapy in the relapsed setting.

Our Take

We are disappointed with the negative recommendation from the FDA panel. We note that in Dec 2011, AstraZeneca had announced its decision to stop the development process of olaparib as maintenance treatment of serous ovarian cancer following an interim analysis of a phase II study (study 19). Our expectations from the candidate are low.

AstraZeneca's pipeline is currently under severe pressure with revenues plunging due to generic competition faced by several key drugs including Seroquel. Additionally, Nexium has also gone off-patent earlier this year.

AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Allergan ( AGN ), Regeneron Pharmaceuticals, Inc. ( REGN ) and Affymax, Inc. ( AFFY ) While Allergan and Regeneron are Zacks Rank #1 (Strong Buy) stocks, Affymax holds a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: REGN , AZN , AGN , AFFY

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