June 25 (Bloomberg) -- AstraZeneca Plc, the drugmaker that rejected a $117 billion takeover offer from Pfizer Inc., failed to win the backing of U.S. advisers for an ovarian cancer treatment the company has resurrected for certain patients.
AstraZeneca should complete a study meant to confirm olaparib’s benefit before the Food and Drug Administration considers approving the drug, agency advisers voted 11-2 today. While the London-based company scrapped plans for the drug in 2011, it revived olaparib after deciding to reanalyze data on patients with a hereditary mutation of the BRCA genes.
If the FDA requires AstraZeneca to complete a confirmatory study before deciding on approval, the company may lose $150 million in sales through 2016, Bloomberg Industries said. The study is expected to produce results at the end of 2015. A delay also would raise questions about AstraZeneca’s view that its experimental medicines were undervalued by Pfizer in the proposed acquisition, according to Bloomberg Industries.
Olaparib appeared to help patients live longer without their disease progressing yet “there are a number of issues that raise concern about that,” Brent Logan, a panel member and biostatistics professor at the Medical College of Wisconsin, said after the vote. “That produces a magnitude of uncertainty.”
AstraZeneca is attempting to gain accelerated approval of olaparib based on a Phase II clinical trial, the middle of three stages of trials usually required for approval. Early FDA clearance would require the drugmaker to complete a final-phase study, called SOLO-2, to stay on the market. Results from that study are expected to be available at the end of 2015, FDA staff members said in a report posted before the panel meeting.
The FDA is expected to decide whether to grant olaparib accelerated approval by Oct. 3. AstraZeneca also is studying the drug in lung and breast cancers.
AstraZeneca will continue to work with the FDA as it reviews the company’s application to gain marketing approval of the drug, said Briggs Morrison, the company’s executive vice president, global medicines development and chief medical officer.
Patients “have few options available to treat this disease,” Morrison said in a statement. “We are disappointed with today’s recommendation, and strongly believe that olaparib has the potential to provide patients with relapsed BRCA-mutated ovarian cancer and their doctors with a much-needed treatment option.”
AstraZeneca’s reanalysis of the drug, known as Study 19, found ovarian cancer patients with the BRCA mutation who took olaparib lived 11.2 months without their disease progressing compared with 4.1 months for those on a placebo. FDA staff members questioned whether the reanalysis skewed the results.
If the difference in progression-free survival isn’t as pronounced, the risks associated with olaparib may outweigh the benefit. Safety concerns include bone marrow suppression, fatigue, nausea and abdominal pain as well as a “small but concern risk” of developing a certain kind of leukemia, according to the report.
Myriad Genetics Inc. is attempting to gain FDA approval for its BRCA gene test as a companion diagnostic with olaparib.
AstraZeneca applied to the FDA in March 2013 for a breakthrough drug designation reserved for therapies that show promise in early studies against serious diseases. A breakthrough therapy is afforded extra FDA help through the approval process. The agency denied olaparib the designation in May 2013.
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