Novartis has been notified of a third case of progressive multifocal leukoencephalopathy (PML) in a patient with relapsing multiple sclerosis (MS) treated with fingolimod (Gilenya).
According to an August 17 notice on the company’s Gilenya Information Center Web page, the diagnosis of PML was based on suggestive clinical symptoms, magnetic resonance imaging findings, and tests for JC virus. The patient did not have prior exposure to natalizumab (Tysabri, Biogen) treatment, which is already associated with increased PML risk.
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The patient has a history of colorectal cancer treated with chemotherapy and radiation treatment, as well as Crohn’s disease, and Novartis says they are currently in “active discussions with external advisors to review details of this case and the role of various risk factors contributing to the development of PML.”
The patient has a history of colorectal cancer treated with chemotherapy and radiation treatment, as well as Crohn’s disease, and Novartis says they are currently in “active discussions with external advisors to review details of this case and the role of various risk factors contributing to the development of PML.”
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