Approved under a Humanitarian Device Exemption, the NovoTTF-100L was fast-tracked to the U.S. market by the FDA for its potential to “benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.” FDA classifies mesothelioma as a rare disease for which there is no cure and little clinical data on.
NovoTTF-100L is an antimitotic device that delivers electric fields at special frequencies to disrupt solid tumor cancer cell division, FDA said. Designed for use with pemetrexed plus platinum-based chemotherapies, NovoTTF-100L is indicated for the treatment of unresectable, locally advanced or metastatic, malignant pleural mesothelioma.
The American Cancer Society (ACS) estimates that between 2,000 and 3,000 new cases of mesothelioma are diagnosed each year in the U.S. The disease has an extremely long incubation period (time between exposure to offending pathogen and development of symptoms), which has been reported to be anywhere from 20 to 50 years.
When they do present, signs and symptoms of mesothelioma include:
- Chest pain
- Painful coughing
- Shortness of breath
- Unusual lumps of tissue under the skin on your chest
- Unexplained weight loss (courtesy of Mayo Clinic)
There are 4 separate and distinct forms of mesothelioma: Pleural, peritoneal, pericardial and testicular, according to the ACS. Pleural, the type of mesothelioma NovoTTF-100L was designed to treat, is the most common form, representing about 75% of all mesothelioma cases.
If you or a loved one has been diagnosed with any type of mesothelioma, get the facts at Schmidt & Clark, LLP. If, after researching the subject and consulting your physician, feel that your development of the disease may have been caused by or contributed to by exposure to asbestos, you should contact our lawyers immediately at (866) 588-0600 to learn more about your legal rights.
ACT NOW – your potential to receive compensation for any injuries is governed by a state-imposed statute of limitations, which means you have a limited amount of time in which to file your claim.