Amgen granted full FDA approval for blood cancer treatment

By Isabel Cameron

- Last updated on GMT

© Getty Images
© Getty Images

Related tags blood cancer drug FDA approval Food and drug administration Leukemia

Amgen has announced that the US Food and Drug administration (FDA) has converted the accelerated approval for its blood cancer treatment Blincyto to a full approval.

Blincyto is now approved for the treatment of adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) of at least 0.1%.

The drug was initially granted an accelerated approval in March 2018, based on data from the single-arm BLAST trial, which showed that the 18-month relapse-free survival (RFS) rate was 56% in efficacy-evaluable patients. In addition, 81.4% of patients achieved undetectable minimal residual disease (MRD).


Blincyto is a BiTE (bispecific T-cell engager) immuno-oncology therapy that targets CD19 surface antigens on B cells.

BiTE molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells.

By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers.

Amgen said it is continuing to advance a ‘robust development plan’ for Blincyto, including studies aimed at treating patients with MRD-negative B-ALL, trials designed to minimize chemotherapy, and the clinical investigation of a subcutaneous formulation, all intended to help address remaining unmet needs for patients.

David Reese, executive vice president of research and development at Amgen, said: "We are pleased the FDA has granted full approval for Blincyto, the first FDA-approved CD19-directed CD3 T-cell engager BiTE immunotherapy and the first to be FDA-approved for MRD in 2018.”

"Today's full approval underscores the clinical benefit of Blincyto for people living with B-ALL, and we look forward to exploring how we can continue to make a significant impact for these patients."

Elias Jabbour, professor of medicine in the department of leukemia, University of Texas, added: "In a Phase 2 study, roughly 80% of adult patients treated with blinatumomab experienced a complete MRD response.”

"The FDA's decision to grant a full approval for blinatumomab further validates the use of this therapy to treat adults and children with B-cell precursor ALL with MRD present following a remission, which is a strong predictor of relapse in this patient population."

Related topics Bio Developments Pipelines

Related news

Show more

Follow us