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FDA Grants Mesothelioma Immunotherapy Vaccine Orphan Drug Designation

In a move that has been highly anticipated and met with great excitement from the medical community, the U.S. Food and Drug Administration has granted orphan drug designation to the innovative immunotherapy vaccine CRS-207. The drug has yielded impressive results in halting mesothelioma tumors in the laboratory.

CRS-207 is being made by the pharmaceutical company Aduro Biotech, and has previously been given orphan drug designation as a treatment for pancreatic cancer, another disease that is extremely difficult to treat. The drug is created from a bacterium called Listeria monocytogenes, which causes listeriosis. It has been weakened and modify in order to evoke an anti-tumor response, and in laboratory tests it has provided a 94 percent rate of either partial response or stabilization of the disease, offering the hope of an additional 7.5 months of survival without the tumors progressing.

According to Dr. Tawee Tanvetyanon, an oncologists at the Moffitt Cancer Center in Tampa, Florida, “This is an exciting therapeutic avenue that will save many more lives, or at least allow extra quality time for mesothelioma patients. It is very promising. It could change the paradigm in the management of mesothelioma.” The vaccine is given prior to standard chemotherapy, and works by evoking an immune response against mesothelin, which is found in higher levels in mesothelioma tumors. The treatment is then followed by a chemotherapy protocol using cisplatin and pemetrexed. The results have been extremely encouraging, as patients have regained weight that they’d previously lost due to loss of appetite, and tumors have been significantly reduced. Dr. Tanvetyanon said, “We have found that the mesothelioma has shrunk considerably when we checked patients with a CT scan following the vaccine and chemotherapy. They recovered their well-being.”

When a drug is given an orphan drug designation by the FDA, it means that it has special status. Tax incentives are offered for continuing research and the manufacturers are qualified for special marketing privileges, including exclusivity for several years. These benefits are provided to encourage drug companies to invest time and money into drugs that would otherwise not be profitable because of the rarity of the conditions that they are designed to treat.

CRS-207 is currently in clinical trials in several cancer centers across the United States, including the Moffitt Cancer Center, the Abramson Cancer Center in Philadelphia, the National Cancer Institute in Bethesda, Maryland, the University of Chicago Medical Center and the University of California at San Francisco.

Terri Oppenheimer

Terri Oppenheimer is an independent writer, editor and proofreader. She graduated from the College of William and Mary with a degree in English. Her dreams of a writing career were diverted by a need to pay her bills. She spent a few years providing copy for a major retailer, then landed a lucrative career in advertising sales. With college bills for all three of her kids paid, she left corporate America for a return to her original goal of writing. She specializes in providing content for websites and finds tremendous enjoyment in the things she learns while doing her research. Her specific areas of interest include health and fitness, medical research, and the law.

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