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FDA Panel Backs Blinatumomab for MRD+ ALL

Jason Harris
Published: Wednesday, Mar 07, 2018

The FDA briefing document for ODAC noted that the safety profile for blinatumomab in this setting was similar to was has been demonstrated with the treatment in patients with relapsed/refractory ALL. The median treatment exposure for the 137 patients was 55 days (range, 1-196). Ninety-one percent of patients had fever, 69% had a neurological toxicity, 7% had cytokine release syndrome, and 2% had sepsis.

Fatal adverse events occurred in 3 patients: fatal atypical pneumonia within 30 days of starting treatment; subdural hemorrhage at the site of a prior hemorrhage <30 days after the last dose of blinatumomab; and sepsis.

Blinatumomab is currently approved by the FDA the treatment of adult and pediatric patients with relapsed or refractory B-cell precursor ALL.
FDA Briefing Document Oncologic Drugs Advisory Committee Meeting BLA 125557 S-013 Blincyto (blinatumomab) Applicant: Amgen, Inc. Published Accessed March 7, 2018. http://bit.ly/2oV6FOq.



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