Amgen blood cancer drug BLINCYTO scores EC approval in pediatric patients

The European Commission (EC) has approved an expanded indication for Amgen blood cancer drug BLINCYTO (blinatumomab) as monotherapy for the treatment of certain form of acute lymphoblastic leukemia (ALL) in pediatric patients aged one year or older.

The pediatric approval of BLINCYTO is for the treatment of patients with Philadelphia chromosome-negative (Ph-) CD19 positive B-cell precursor and whose condition is refractory or relapsed after getting more than two prior therapies or in relapsed state after getting prior allogeneic hematopoietic stem cell transplantation.

David M. Reese – executive vice president of Research and Development at Amgen, commenting on the expanded indication for Amgen blood cancer drug BLINCYTO in Europe, said: “Historically, children with relapsed or refractory ALL have had limited pharmacologic options beyond chemotherapy, resulting in poor outcomes.

“This approval for BLINCYTO provides physicians across Europe with an important new immunotherapy option for these young, heavily pretreated patients, delivering on Amgen’s commitment to making a difference in the lives of cancer patients.”

Amgen blood cancer drug BLINCYTO secures EC approval for the treatment of acute lymphoblastic leukemia in pediatric patients.

Amgen blood cancer drug BLINCYTO secures EC approval for the treatment of acute lymphoblastic leukemia in pediatric patients. Photo courtesy of Coolcaesar/Wikipedia.org.

BLINCYTO’s new EC approval was given based on the data from the phase 1/2 ‘205 single-arm trial which assessed the efficacy and safety of the blood cancer drug in 93 pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

BLINCYTO is a bispecific T cell engager (BiTE) immunotherapy, which was approved in the European Union in 2015 for the treatment of adults having Ph- relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The Amgen blood cancer drug functions by binding to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of effector T cells.

BLINCYTO has full approval in the US for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia in both adults and children.

In April 2018, the Amgen blood cancer drug was approved under accelerated approval for the treatment of B-cell precursor acute lymphoblastic leukemia in both adults and children whose condition is in first or second complete remission with minimal residual disease (MRD) more than or equal to 0.1%.

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