Mesothelioma is a difficult cancer to treat because it is extremely aggressive and metastasizes quickly. Thus far, there are have few treatments that increase quality of life or extend life very much once a diagnosis of Mesothelioma is made.
Recently, Bayer announced that the FDA approved its drug, BAY 94-9343, as an orphan drug for the treatment of Mesothelioma. This drug is an ADC, or Antibody-Drug Conjugate. This type of drug is also known as an immunotoxin or immunoconjugate. In the case of this particular drug, it targets the mesothelin compound, which is prevalent in Mesothelioma.
“Orphan drug” status is given to medications that are used to diagnose and/or treat rare diseases that are difficult to treat. In these cases, very few viable treatment options exist. In the case of Mesothelioma, it claims about 2,500 lives each year in the USA. It is considered one of the rarest forms of cancer and is extremely difficult to treat.
The purpose of “orphan drug” status is to help drugs like BAY 94-9343 get through the testing phase and into the hands of the people that so desperately need them. When these types of drugs are developed, the drug company usually receives tax credits that can be used for clinical trial expenses, so the drug can get into the market place quicker. In the case of orphan drugs like BAY 94-9343, the drug company gets exclusive rights to market the drug in the USA, and they are exempt from paying the FDA fees that go along with releasing most new drugs.
The purpose of these benefits and breaks is to get the drug on the market quicker, in hopes of saving lives that may not otherwise have a chance. Orphan drugs are used in the cases of rare and deadly diseases, and thus, must be tested and approved faster than drugs in other categories.
The testing for BAY 94-9343 began in September of 2011 at the Bayer drug company. It was tested for safety and effectiveness against solid tumors, including Mesothelioma tumors. Currently, this drug is being used to treat Mesothelioma patients at 3 different treatment centers in the United States of America. Clinical trials continue with the orphan drug BAY 94-9343, along with other drugs in the testing phase for treatment of Mesothelioma.
Doctors, patients, pharmacists, scientists, and drug manufacturers are hopeful that this drug and others like it will be effective in slowing and even stopping Mesothelioma and other solid tumor cancers. There is hope in the fight against Mesothelioma, and “orphan drug” status helps remove some of the red tape and get the drugs to the patients quickly.