FDA Panel Spurns Approval For AstraZeneca's Ovarian Cancer Drug Olaparib

A U.S. Food and Drug Administration advisory committee has Wednesday recommended against the accelerated approval for AstraZeneca Plc's (AZN) ovarian cancer drug olaparib based on mid-stage study results. The FDA Oncologic Drugs Advisory Committee voted 11 to 2 that the current evidence from clinical studies does not support an accelerated approval for use of olaparib.

The investigational drug is indicated as a maintenance treatment for women with platinum-sensitive relapsed ovarian cancer who have the germline BRCA (gBRCA) mutation, and who are in complete or partial response to platinum-based chemotherapy. The sales potential for this drug is reportedly pegged at $2 billion.

"Patients with germline BRCA-mutated serous ovarian cancer have few options available to treat this disease. 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," Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca said.

Olaparib is an investigational, potential first-in-class oral poly ADP ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to selectively induce cancer cell death. It has the potential to be the first PARP inhibitor available for patients with BRCA mutated platinum-sensitive relapsed serous ovarian cancer.

However, the advisory committee were not convinced about the clinical benefits that warrant an early approval for this drug as a maintenance therapy. It questioned the potential side effects of the drug as well as uncertainties about the efficacy data demonstrating an improvement on progression-free survival.

Meanwhile, AstraZeneca noted that the advisory committee provides non-binding expert advice and recommendations for consideration by the FDA, but the final decision on approval is always made by the FDA.

The FDA granted priority review status for the NDA in April and set a Prescription Drug User Fee Act (PDUFA) action date of October 3, 2014. AstraZeneca filed the US regulatory submission for olaparib in February 2014.

London-based AstraZeneca had earlier in December 2011 shelved plans for Olaparib phase III study after it had failed a study for ovarian cancer, which showed overall survival in the olaparib arm was 34.9 months compared to 31.9 months for placebo.

The company also incurred a $285 million writeoff at that time, but the charge was reversed in the third quarter of 2013 following the restart of the program. It is conducting a confirmatory Phase III study of the PARP inhibitor, dubbed SOLO-2.

"We look forward to continuing to work with the FDA as it evaluates the Advisory Committee recommendation and completes its review of the application. In the meantime, we are continuing with our Phase III clinical programme to evaluate the benefit of olaparib for this patient population. We aim to have completed this study by the end of 2015," Morrision added.

Ovarian cancer is the eighth most commonly diagnosed cancer in women and the fifth leading cause of cancer death among women worldwide, mainly because it is often diagnosed late and has an extremely poor prognosis. An estimated 22,000 new cases were diagnosed and 14,270 deaths occurred from the disease in the US in 2014.

AstraZeneca is currently seeking new drugs in order to overcome the revenue loss from the patent loss on some of their blockbuster drugs. US drugmaker Pfizer, Inc.(PFE) had in late May abandoned its pursuit to buy AstraZeneca after three sweetened offers were rejected, with the last valued at $69.3 billion pounds or $116.6 billion.

AZN closed Wednesday's regular trading session at $74.31, up $0.67 or 0.91% on a volume of 2.14 million shares.

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