Amgen Korea has received an expanded indication for Blincyto, a treatment for acute lymphoblastic leukemia (ALL), for treating minimal residual disease (MRD) in relapsed and refractory ALL.

Amgen Korea's ALL treatment Blincyto has received expanded indication from the Ministry of Food and Drug Safety. (Amgen Korea)

MRD refers to a state of the disease where doctors detect malignant cells through more detailed tests such as flow cytometry and polymerase chain reaction even after the patients reach complete remission (CR). MRD-positive patients may still have 10 to the 10th power malignant leukemia cells, even after achieving full remission, causing a recurrence. MRD is also known to be a powerful predictor of recurrence in ALL patients.

According to the U.S. National Comprehensive Cancer Network (NCCN) guidelines and the European Society of Oncology (ESMO), adult and adolescent ALL patients who are MRD positive are considered high-risk groups, emphasizing the importance of MRD monitoring to aid in treatment decisions.

With the expansion of this indication, hospitals can use Blincyto not only to treat relapsed or refractory B cell precursor acute lymphoblastic leukemia (BCP-ALL) in adults and children but also to treat adults and children BCP-ALL patients in the first or second remission state with an MRD of 0.1 percent.

Among all therapies released in Korea, Blincyto is the first drug that won the approval for MRD treatment from the Ministry of Food and Drug Safety.

The ministry approved the expanded indication after Amgen confirmed its efficacy through a phase 3 BLAST study. The study included 116 patients aged 18 and above with BCP-ALL.

As a result of the study, 88 patients, or 78 percent of the total 113, showed a complete MRD treatment response after a one week cycle of Blincyto administration, meeting the primary endpoint.

"About 60 percent of patients with ALL experience recurrence even after first-line treatment even if CR is reached, which is a high possibility of recurrence in the case of MRD," Amgen Korea CEO Rho Sang-kyung said. "Therefore, a treatment option was needed to remove residual leukemia cells, and we are pleased that Blincyto will become the first drug in Korea to play that role."

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