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Onconase® Granted Orphan Drug Status for Mesothelioma Treatment in Australia
April 1, 2005 — Australia has granted “orphan drug status” to the chemotherapy drug Onconase® (ranpirnase), as a mesothelioma treatment. This label allows Onconase® to receive priority review over other drugs. Also, certain fees are waived for Alfacell, the drug’s manufacturer.
Onconase® is a ribonuclease, which is an enzyme that speeds up the breakdown of RNA, a nucleic acid that copies genetic information and translates it into proteins. Onconase® may inhibit cancer cell growth by interrupting protein synthesis. In a preliminary United States study by Alfacell of 105 mesothelioma patients treated with Onconase®, the one–year and two–year survival rates were 34.3% and 21.6 %, respectively (J Clin Oncol. 2002 Jan 1; 20(1): 274–81). This compares well with the usual survival rate of 6 to 8 months without treatment.
A more advanced clinical trial is now underway in the United States, Australia, Canada, and Europe, to determine the safety, effectiveness, and side effects of Onconase® on mesothelioma patients. One group receives Onconase® plus a standard chemotherapy drug, doxorubicin. The control group receives doxorubicin alone. Researchers will compare members of each group by looking at their survival rates, observing if their pain has been reduced, and recording the size and growth of their mesothelioma tumors.
To be eligible for the clinical trial, patients must not be candidates for mesothelioma surgery. Also, they may not have received chemotherapy treatment more than once before. For more details and a list of mesothelioma treatment centers taking part in the study, see National Cancer Institute Clinical Trials.
Europe Also Gives Priority to Onconase®
Onconase® is also designated as an orphan drug for mesothelioma treatment in Europe. The United States has not given any special status to Onconase®. At present, the only drug approved for mesothelioma in the United States is ALIMTA® (pemetrexed). ALIMTA® plus the standard chemotherapy agent, cisplatin, may be used to treat pleural mesothelioma, a form of the disease that attacks the lining of the chest and lungs.
For more details about chemotherapy, surgery, and other mesothelioma treatment choices, see Mesothelioma Treatment Options. For information about your legal rights concerning mesothelioma, please feel free to contact us at Brayton Purcell. We have been handling cases involving mesothelioma and asbestos exposure for over 20 years and can provide support, information, and excellent advocacy.
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