Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
FDA Expands Blincyto Indication
Amgen news release; 2017 July 11
The FDA has expanded the indication of Blincyto for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Indications: Blincyto is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of relapsed or refractory B-cell precursor ALL in adults and children.
Dosage and Administration: A treatment course consists of up to 2 cycles of Blincyto for induction followed by 3 additional cycles for consolidation and up to 4 additional cycles of continued therapy.
Efficacy and safety: Approval is based on data showing that Blincyto nearly doubled median overall survival (to 7.7 months) when compared with standard of care chemotherapy.
Side effects/risks: The most common adverse reactions are infections, pyrexia, headache, infusion-related reactions, anemia, febrile neutropenia, thrombocytopenia, and neutropenia.
FDA grants full approval for Blincyto (blinatumomab) to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults and children. [news release]. Thousand Oaks. CA: Amgen. July 11, 2017. http://www.prnewswire.com/news-releases/fda-grants-full-approval-for-blincyto-blinatumomab-to-treat-relapsed-or-refractory-b-cell-precursor-acute-lymphoblastic-leukemia-in-adults-and-children-300486597.html. Accessed July 16, 2017.
Blincyto [package insert]. Thousand Oaks, CA: Amgen. 2017. http://pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/blincyto/blincyto_pi_hcp_english.ashx. Accessed July 16, 2017.