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FDA Approves New Mesothelioma Treatment for Orphan Drug Status

Mesothelioma is a deadly disease for which there is no cure. There are treatments that can be used to extend a patient’s life for a matter of months, or, in the best cases, years. However, once a patient is diagnosed with malignant mesothelioma, he or she usually only has a very short time left to live.

pills5.jpgThe reason for this is because of the manner in which asbestos affects the human body and how mesothelioma develops. Once a person is exposed to deadly asbestos fibers, these fibers can become trapped in a person’s lungs or other internal organs. They can become embedded in the lining of a protective layer of tissue known as the mesothelium.

At this point, the fibers are virtually impossible for doctors to detect early on. Even if they could, there is as of right now nothing doctors can do to remove them or treat a victim.

Over a relatively long period of time, about 20 to 50 years, the asbestos particles will metastasize into malignant mesothelioma. However, this is not to say all victims will be elderly by the time mesothelioma presents itself. There have been cases where young children were exposed to asbestos when their parents or other family member living with them came home from work covered in asbestos fibers. Children would hug their parents and breathe in the fibers.

In an effort to help patients suffering from the horrible disease, scientists have been working toward more effective treatments and eventually a cure for malignant mesothelioma. According to a recent news article from Healio, the FDA has just granted orphan drug status to a medication known as CRS-207.

CRS-207, from Aduro Biotech, is approved for patients who have not received any other therapy for malignant mesothelioma and who are also not able to undergo surgical resection of the affected area. As our Boston mesothelioma injury attorneys can explain, an orphan drug is one designed to treat what is considered a relatively rare disease. It is easier to get FDA approval to market the drug because it does not affect as many patients. One of the reasons for having an organ drug status is because otherwise, pharmaceutical companies might be less inclined to spend money on developing and marketing drugs that would not generate a significant amount of sales to make the drug profitable.

While mesothelioma affects thousands of Americans each year, this is considered a very rare disease, when compared to a condition such atrial fibrillation (Afib). Drug companies are willing to spend millions developing and marketing Afib drugs, because they will generate billions of dollars of sales in return.

Currently, this drug is still in the clinical trial phase and will still need to undergo more testing before final approval, but the manufacturer has issued several press releases claiming promising results for malignant mesothelioma patients. It should be noted, regardless of orphan drug status, FDA is generally more willing to allow experimental medications be tested on human patients if the drug is designed for treatment of a terminal illness for which there is real no other better alternative. The FDA sometimes refers to this a compassionate use exception, depending upon the circumstances of a particular case.


If you or a loved one is diagnosed with mesothelioma in Boston, call for a free and confidential appointment at 1-888-367-2900.

Additional Resources:
FDA grants orphan drug designation to CRS-207 for mesothelioma , , Healio, March 27, 2015
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