FDA Grants Full Approval to Leukemia Treatment
The US Food and Drug Administration has granted full approval to Blincyto (blinatumomab) for the treatment of adult and pediatric patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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Blincyto was previously granted accelerated approved as the first single-agent immunotherapy for the treatment of Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL, and is the first and only approved CD19-directed CD3 bispecific T cell engager immunotherapy.
Approval of Blincyto was based on the results from 2 clinical trial that demonstrated a superior improvement in the median overall survival. Patients receiving Blincyto had a median overall survival of 7.7 months compared with 4 months among patients who received standard of care chemotherapy.
Common adverse events associated with treatment included infections, pyrexia, headache, infusion-related reactions, anemia, febrile neutropenia, thrombocytopenia, and neutropenia. Serious adverse reactions were reported in 62% of patients, and the most common were febrile neutropenia, pyrexia, sepsis, pneumonia, overdose, septic shock, cytokine release syndrome, bacterial sepsis, device related infection, and bacteremia.
Adverse reactions that were observed more frequently in children included pyrexia, hypertension, anemia, infusion-related reaction, thrombocytopenia, leukopenia, and weight gain.
Furthermore, Blincyto includes a box warning for cytokine release syndrome and neurologic toxicities that can be life-threatening. Patients should be monitored for signs of these conditions, and should cease treatment according to the prescribing information if symptoms manifest.
—Melissa Weiss
Reference:
FDA grants full approval for BLINCYTO® (blinatumomab) to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults and children [press release]. Thousand Oaks, CA: Amgen; July 11, 2017. http://wwwext.amgen.com/media/news-releases/2017/07/fda-grants-full-approval-for-blincyto-blinatumomab-to-treat-relapsed-or-refractory-bcell-precursor-acute-lymphoblastic-leukemia-in-adults-and-children/. Accessed July 12, 2017.