Patient In New Rituxan PML Case Had “Complex” History
This article was originally published in The Pink Sheet Daily
Executive Summary
Label warning updated after single death in long-term RA trial.
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The new label warning on Rituxan about a rheumatoid arthritis patient who died of progressive multifocal leukoencephalopathy during a clinical trial updates an existing caution about PML when used against diseases for which the drug is not approved. But, the study participant had "multiple confounding issues," JMP Securities analyst Geoffrey Meacham notes in remarks on Sept. 11, the same day FDA's MedWatch disclosed the news. Doctors are being advised in a letter about the patient - who got the final dose 18 months before death, and underwent chemotherapy for oropharyngeal cancer nine months before the PML diagnosis. The patient, given Rituxan (rituximab) in a long-term extension study, had a "complex medical and rheumatologic history, including Sjogren's syndrome and undetectable complement C4 levels," according to the letter from Genentech and partner Biogen Idec. Rituxan is approved for RA and non-Hodgkin's lymphoma. Meacham called it "unclear that the PML case can be directly attributed to Rituxan" and noted that anti-tumor necrosis factor drugs as a class have been associated with autoimmune complications. Rituxan probably has a safety profile no more severe than the others, he said. Biogen's Tysabri (natalizumab) for multiple sclerosis and Crohn's disease also has been linked to PML, although recently reported new cases did not bring an especially strident label warning from FDA (1 (Also see "FDA Still Behind Tysabri Monotherapy" - Pink Sheet, 25 Aug, 2008.)). - Randall Osborne ([email protected]) |