ONCONASE, a drug to treat mesothelioma and other cancers, is scheduled at the end of January 2009 to be the subject of a pre-NDA (New Drug Application) meeting of the Food and Drug Administration (FDA). This is a critical step to be taken before the drug’s manufacturer, Alfacell, can complete its New Drug Application. The intention of the pre-NDA meeting will be for the FDA to give ideas to Alfacell to finish its application. Whether or not the drug will be approved cannot be contested until after the finalized NDA is submitted. During the Phase IIIb trials for ONCONASE, only those patients whose mesothelioma was not successfully treated by other chemotherapies saw a statistical improvement in their condition with ONCONASE.
The lack of an impact by Alfacell’s drug on patients who were treated by other chemotherapy drugs might lead the FDA to not approve ONCONASE. Alfacell is looking to ask the FDA to allow for it to finish its rolling NDA within 48 hours of the pre-NDA meeting. In doing so, the company could get pointers from the FDA to better tailor its application, which will improve the chances of the drug being approved. Shortly after the completion of the NDA, the FDA will view the results of the clinical trials of the drug. If ONCONASE is approved, it will open the way in the near future for offering this drug to unresectable malignant mesothelioma (UMM) patients who have failed to be treated with other chemotherapies. ONCONASE has already been given fast track status to lessen the amount of time required in the FDA approval process. It also is classified as an orphan drug in the United States and Europe. This status is given to drugs that treat patients with rare diseases that affect fewer than 200,000 people.