FDA Panel Recommends Against Accelerated Approval of Olaparib

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In 2014, it is estimated that 14,270 deaths occurred from ovarian cancer in 2014. Due to its late diagnosis and poor prognosis, this disease is the fifth leading cancer-related cause of death for women worldwide. Some researchers and clinicians were hoping that the drug olaparib could mitigate this problem.

 

The FDA Oncologic Drugs Advisory Committee voted 11 to 2 against the accelerated approval of olaparib, AstraZeneca’s ovarian cancer drug, due to current evidence from clinical studies. As an investigational, potential first-in-class oral poly ADP ribose polymerase inhibitor, olaparib would be used as a maintenance treatment for patients with platinum-sensitive relapsed ovarian cancer with the gBRCA mutation and who have experienced partial or complete response to platinum-based chemotherapy. The drug would be the first PARP inhibitor for those patients, and it would selectively induce cancer death by exploiting tumor DNA repair pathway deficiencies.

 

The advisory committee, however, questioned the drug’s side effects and efficacy data. Although the advisory committee gives recommendations, the FDA ultimately decides whether a drug will receive approval.

 

AstraZeneca executive vice president Briggs Morrison, MD, said that AstraZeneca is disappointed with the advisory committee’s recommendation. After losing the patent on some of their drugs, the company is looking for new drugs to overcome their revenue loss. Olaparib has a sales potential of $2 billion.

New Study May Pave Way for Detecting Ovarian Cancer Earlier
FDA Panel Recommends Against Accelerated Approval of Olaparib

A U.S. Food and Drug Administration advisory committee has 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.

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