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Blincyto approved to reduce relapse risk in certain leukemia patients




Cancer medication Blincyto (blinatumomab) has received accelerated approval as a treatment to reduce the risk of relapse in certain patients with B-cell precursor acute lymphoblastic leukemia (ALL). Under the latest US Food and Drug Administration (FDA) approval, Blincyto is indicated for adults and children with ALL who are in remission, yet still have minimal residual disease (MRD). 

B-cell precursor ALL is an aggressive form of cancer in which excessive quantities of B-cell lymphocytes are produced by the bone marrow. It is the most common form of ALL, accounting for around three-quarters of cases, according to data from the National Cancer Institute. 

In patients with ALL, stem cells turn into leukemia cells, which results in less room in the blood for healthy cells, such as white blood cells, red blood cells, and platelets, which increases the risk of infection, anemia and easy bleeding. Factors that increase the risk of ALL include being male, over 70 years of age, past treatment with chemotherapy or radiation therapy, exposure to high levels of radiation, and certain genetic disorders, such as Down syndrome. 

Blincyto is an antineoplastic monoclonal antibody administered via injection. The Amgen Inc drug is indicated as a treatment for Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL  and gained FDA approval in December 2014.

The latest approval was granted under the accelerated approval pathway, which enables the FDA to approve drugs for serious conditions if there is an unmet medical need. It also necessary to prove the drug in question has effects likely to render a clinical benefit to patients. Blincyto was also granted Priority Review and Orphan Drug designation. 

Efficacy of the drug as a treatment for MRD-positive ALL was demonstrated in a single-arm clinical trial of 86 patients in first or second complete remission who had detectable MRD in at least one out of 1,000 bone marrow cells. More than half the patients involved in the trial remained alive and in remission for a minimum of 22.3 months, with 70 patients achieving undetectable MRD. 

Common Side Effects of Blincyto: 

Infection (caused by either bacteria or other unspecified pathogens)

Fever

Headaches

Infusion-related reactions

Low counts of certain blood cells, leading to conditions such as neutropenia or anemia 

Febrile neutropenia

Low platelet levels in the blood

Other Serious Risks Associated with Blincyto:

The medication carries a warning on the box notifying healthcare providers and patients that some participants in the clinical trial experienced low blood pressure levels and problems breathing at the start of the course of treatment. Some also experienced side effects relating to the nervous system and cognitive problems. 

Infection

Pancreatic inflammation

Preparation and administration errors

Possible adverse effects on a patient’s ability to drive or operate machinery

The main treatment for ALL in adults is long-term chemotherapy. This can cause sided effects, such as a low white blood cell count, so physicians may also prescribed other drugs to treat or prevent these side effects. Commonly used chemotherapy drugs include Oncovin (vincristine) and Adriamycin (doxorubicin). ALL patients whose leukemia cells have the Philadelphia chromosome may also be prescribed a targeted drug such as Gleevec (imatinib).