FDA Updates REMS and Black Box Warnings for Blinatumomab

May 30, 2019
FDA Updates REMS and Black Box Warnings for Blinatumomab

In May 2019, the U.S. Food and Drug Administration (FDA) added new clarifications to its risk evaluation and mitigation strategy (REMS) and black box warnings for blinatumomab (Blincyto®). Blinatumomab is a bispecific, CD19-directed CD3 T-cell engager indicated for the treatment of adults and children with (a) B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% or (b) relapsed or refractory B-cell precursor ALL.

BOXED WARNING: Cytokine Release Syndrome (CRS)

BOXED WARNING: Neurologic Toxicities

OTHER SERIOUS RISKS: Preparation and Administration Errors

For more detailed safety information, refer to the FDA-reviewed REMS Fact Sheet (http://click.hg-email.com/?qs=7a6493719ab12c8d4a285282da244d58e2ba47beca4c71e8e8cfdca90479e1849d99b64e9ea6fa025a642e53805d41f260301c8f65a9a852), the full prescribing information (https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/blincyto/blincyto_pi_hcp_english.pdf), and Amgen’s Blincyto REMS website (http://click.hg-email.com/?qs=7a6493719ab12c8d6ec66deea2b8fddaeeeb48d97c85d22e10e6dc4a42b192ca7af722008e8f8bfdfa6ff2cd6e88fab5bda2bf41487ac6f2).

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