FDA Approves Blincyto for B-Cell Precursor ALL in Remission With MRD Presence

Share this content:
This FDA approval makes blinatumomab the first approved treatment for patients with MRD-positive ALL.
This FDA approval makes blinatumomab the first approved treatment for patients with MRD-positive ALL.

The Food and Drug Administration (FDA) has granted accelerated approval and Priority Review to Blincyto (blinatumomab; Amgen) for the treatment of patients with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). Patients in remission with MRD presence may have a higher risk of relapse.

The accelerated approval marks Blincyto, a bispecific CD19-directed CD3 T-cell engager, as the first approved treatment for patients with MRD-positive ALL. It is already approved to treat relapsed or refractory B-cell precursor ALL. Additional data from randomized controlled trials are needed to confirm that achieving undetectable MRD with Blincyto improves survival or disease-free survival in patients with ALL. 

A single-arm trial (N=86) evaluated Blincyto in ALL patients in first or second complete remission with detectable MRD in at least 1 of 1,000 cells in their bone marrow. Efficacy was measured according to achievement of undetectable MRD in an assay that could detect at least 1 cancer cell in 10,000 cells following 1 cycle of Blincyto; hematological relapse-free survival was also measured. The data showed 70 patients achieved undetectable MRD and more than 50% survived in remission for at least 22.3 months.

Common adverse effects include infections, pyrexia, headache, infusion related reactions, neutopenia, anemia, febrile neutropenia, and thrombocytopenia.

Blincyto is available as a 35mcg strength lyophilized powder for intravenous (IV) infusion after reconstitution.

For more information call (800) 772-6436 or visit FDA.gov.

You must be a registered member of ONA to post a comment.

Sign Up for Free e-newsletters



Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs