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FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease
- Source :
- Clinical Cancer Research. 25:473-477
- Publication Year :
- 2019
- Publisher :
- American Association for Cancer Research (AACR), 2019.
-
Abstract
- On March 29, 2018, the FDA granted accelerated approval for blinatumomab (Blincyto; Amgen, Inc.) for the treatment of adults and children with B-cell precursor acute lymphoblastic leukemia (BCP ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Blinatumomab is a CD3xCD19 bispecific antibody approved previously for the treatment of relapsed or refractory BCP ALL. The basis for this accelerated approval was a single-arm trial. For the 86 patients in first and second complete remission with MRD ≥ 0.1%, conversion to MRD < 0.01% was achieved after one cycle of blinatumomab by 85.2% [95% confidence interval (CI): 73.8%, 93.0%] and 72.0% (95% CI: 50.6%, 87.9%), respectively, and the estimated median hematologic relapse-free survivals (RFS) were 35.2 months (95% CI: 0.4–53.5) and 12.3 months (95% CI: 0.7–42.3), respectively. Hematologic RFS was considered substantial independent of whether patients underwent subsequent allogeneic stem cell transplantation. The safety profile for blinatumomab was established in prior studies, and no new safety signals were observed in the new population. Cytokine release syndrome and neurotoxicity remain significant risks. The FDA is requiring confirmation of clinical benefit in a randomized trial.
- Subjects :
- Adult
Male
0301 basic medicine
Cancer Research
medicine.medical_specialty
Neoplasm, Residual
Adolescent
Gastroenterology
law.invention
Young Adult
03 medical and health sciences
Antineoplastic Agents, Immunological
0302 clinical medicine
Randomized controlled trial
Refractory
law
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Internal medicine
Antibodies, Bispecific
medicine
Humans
Drug Approval
B cell
Aged
Aged, 80 and over
business.industry
Remission Induction
Middle Aged
Prognosis
medicine.disease
Combined Modality Therapy
Minimal residual disease
Confidence interval
Transplantation
Cytokine release syndrome
Treatment Outcome
030104 developmental biology
medicine.anatomical_structure
Oncology
030220 oncology & carcinogenesis
Female
Blinatumomab
business
medicine.drug
Subjects
Details
- ISSN :
- 15573265 and 10780432
- Volume :
- 25
- Database :
- OpenAIRE
- Journal :
- Clinical Cancer Research
- Accession number :
- edsair.doi.dedup.....7606fcd3599fd2b7759fefbd480ff2f7