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Blincyto by Amgen, Inc. Approved by FDA with Boxed Warning

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Bonnie Harp3 years ago

The Associated Press (AP) reports that the Food and Drug Administration (FDA) has announced approval of Amgen, Inc.’s Blincyto (blinatumomab) to treat an uncommon acute lymphoblastic leukemia, Philadelphia Blincyto is the first anti-CD19 immunotherapy drug to be approved by the FDA.

The new drug does carry a black box warning label addressing adverse events including cytokine release syndrome (CRA) and neurological toxicities.

About Blincyto’s FDA Approval

Blincyto was admitted into the FDA breakthrough therapy designation program for quicker approval when Amgen, Inc. offered substantial evidence indicating that the treatment may be a more effective option than current methods for treating B-cell ALL.  The FDA grants breakthrough therapy designation to elected drugs that demonstrate improvement in rare disease treatment.

A preliminary clinical evaluation of Blyncyto’s effectiveness was conducted on 185 adults that suffer[ed] from relapsed or refractory Philadelphia chromosome-negative B-cell ALL.  Each subject was infused by Blincyto’s immunotherapy and monitored for a period of four weeks.  Complete remission was evident in 32% of subjects.

Blincyto will be available to patients due to the FDA’s accelerated approval program. Earlier access to the treatment will be granted while Amgen, INC. conducts further FDA required investigation of the drug’s effectiveness.

Blincyto was originally to be approved in May 2015. The positive outcomes of preliminary studies have resulted in approval five months prior to Blincyto’s goal.

About Amgen, Inc.’s Blincyto

What does Blincyto treat?

Blincyto has been approved to treat a rare form of cancer, Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), a rapid form of lymphoblastic leukemia that causes bone marrow to produce an overabundance of premature white blood cells, B-cell lymphoblasts. 

According to The National Cancer Institute, precursor B-cell ALL is projected to affect over 6,000 in 2014—approximately 1,440 patients are expected to die from the disease.

How does Blincyto work?

Blincyto is the first FDA approved immunotherapy drug to engage the body’s T-cells to fight disease. Immunotherapy treatments fight diseases by engaging the immune system; Blincyto specifically mediates through the CD19 protein and CD3, which are found on B-cell lymphoblasts and T-cell lymphocytes, respectively. 

Immunotherapies are most commonly used in regard to leukemia, specifically when a patient has had no luck with prior treatment.

Are there risks in Blincyto treatment?

The FDA has approved Blincyto with warnings of cytokine release syndrome (CRA) and neurological toxicities.  The drug is marked with a boxed warning of these side effects.  Less severe side effects of Blincyto are headache, fever, swelling, tiredness, digestive issues and tremor.

Black box wearnings are reserved for drugs that carry a significant risk of serious or life-threatening adverse events.

Blincyto is still in the early stages of approval, thus its availability is under Risk Evaluation and Mitigation Strategy. 


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