The drug ruxolitinib, used to treat intermediate or high risk myelofibrosis, has been associated with the development of progressive multifocal leukoencephalopathy (PML) in a 75-year-old man. It is not clear whether ruxolitinib caused the PML. (An association does not necessarily mean there is a cause and effect.)
PML is a potentially fatal condition in which the white matter insulating the nerve cells in the brain is destroyed. Myelofibrosis is a bone marrow cancer in which the marrow, where the body makes blood cells, is replaced by scar tissue.
Ruxolitinib is prescribed to treat myelofibrosis. Other treatments for myelofibrosis are stem cell or bone marrow transplants. The disease is rare, occurring in 16,000 to 18,500 patients in the U.S. Ruxolitinib is made by Incyte and sold as Jakafi in the U.S. It is sold elsewhere in the world as Jakavi and is made by Novartis.
Independent investigators are trying to determine if the drug did cause the PML.
A possible link between Jakafi and PML could slow the use of the medication, although a diagnostic test might exclude patients prone to the disease from taking it. This would allow the remainder of patients eligible to take it.
The U.S. Food and Drug Administration (FDA) approved ruxolitinib in November 2011. It was approved in Europe in August 2012. Analysts, who assess the potential for sale of the drug, say other future uses of the drug in patients such as those with polycythemia vera, essential thrombocythemia, and solid tumors could make it a “blockbuster.”
If you or someone you love is suffering from the effects of PML, you may qualify for compensation if it is linked to medication use. To learn more, contact our PML lawyers today.