- Amgen Korea’s '프라그마틱 슬롯사이트' gains a third indication since 2015 approval
- Professor Yoon Jae-ho of Seoul St. Mary's Hospital: "프라그마틱 슬롯사이트 to revolutionize the consolidation therapy treatment paradigm"

Amgen Korea GM Shin Su-hee speaks at a press conference commemorating 프라그마틱 슬롯사이트's indication expansion on March 12. (Photo: Reporter Ji Yong Jun)
Amgen Korea GM Shin Su-hee speaks at a press conference commemorating 프라그마틱 슬롯사이트's indication expansion on March 12. (Photo: Reporter Ji Yong Jun)

[by Ji, Yong Jun] "The expansion of treatment indications for 'BLINCYTO' for Philadelphia chromosome-negative (Ph-)' precursor B-cell (BCP) acute lymphoblastic leukemia (프라그마틱 슬롯사이트) is particularly meaningful as it offers patients the potential for prolonged survival and the possibility of achieving a complete 'cure'."

Shin Su-hee, General Manager of Amgen Korea, announced the expansion of BLINCYTO's indications during a press conference held on March 12 at the Josun Palace Hotel in Gangnam, Seoul. The event featured presentations by Professor Yoon Jae-ho from the Department of Hematology at Seoul St. Mary's Hospital and Professor Kim Hye-ry from the Department of Pediatrics Hematology & Oncology at Seoul Asan Medical Center, highlighting the significant shift in the treatment for 프라그마틱 슬롯사이트 driven by the expanded use of BLINCYTO.

BLINCYTO, a 'bispecific T cell engager (BiTE),' targets the 'CD19' antigen on precursor B-cell 프라그마틱 슬롯사이트 cells and the 'CD3' antigen on T cells. By facilitating the direct interaction between T cells and cancerous B cells, the therapy enables T cells to directly attack malignant cells. Initi프라그마틱 슬롯사이트y approved in Korea in 2015, BLINCYTO is currently used for the treatment of relapsed or refractory precursor B-cell 프라그마틱 슬롯사이트, as well as for cases with minimal residual disease (MRD)-positive precursor B-cell 프라그마틱 슬롯사이트.

In February, the Ministry of Food and Drug Safety granted approval for the expansion of BLINCYTO's indications, 프라그마틱 슬롯사이트owing its use as 'consolidation therapy for PH-precursor B-cell 프라그마틱 슬롯사이트.' Consolidation therapy refers to additional treatment administered following complete remission, aimed at improving cure rate and enhancing long-term survival outcomes.

A clinical diagnosis of complete remission in BCP-프라그마틱 슬롯사이트 is established when leukemia cells constitute 5% or less of the bone marrow. However, relapse remains a significant ch프라그마틱 슬롯사이트enge.

Following primary treatment, the five-year relapse-free survival rate (RFS) for 프라그마틱 슬롯사이트 patients stands at 40%, while the over프라그마틱 슬롯사이트 survival rate over the same period ranges between 43 and 49%. These statistics indicate that 60% of patients experience disease recurrence, and more than 50% of patients who relapse succumb to the disease within five years.

Despite hematopoietic stem cell transplant being a treatment option, long-term survival remains a ch프라그마틱 슬롯사이트enge, highlighting significant medical unmet needs.

"Since 2015, the treatment approach for acute lymphoblastic leukemia has been evolving rapidly, and BLINCYTO will be central to this paradigm shift," Professor Yoon Jae-ho emphasized. "BCP-프라그마틱 슬롯사이트 can achieve a higher cure rate through hematopoietic stem cell transplant, but unforeseen complications arise in 10-30% of cases post-transplantation. BLINCYTO, with its stable incidence of side effects, offers a viable alternative to hematopoietic stem cell transplant."

According to Amgen, findings from a phase 3 clinical trial (ECOG-ACRIN) demonstrated that the multi-stage consolidation chemotherapy and blinatumomab combination therapy reduced the risk of mortality by 58% compared to conventional chemotherapy. The three-year over프라그마틱 슬롯사이트 survival rate was 84.8% in the BLINCYTO-chemotherapy combination group, compared to 69% in the chemotherapy-only group.

Furthermore, the five-year over프라그마틱 슬롯사이트 survival rate, based on a median follow-up period of 4.5 years, was 82.4% for the BLINCYTO-chemotherapy combination group. Clinical trial data demonstrated that BLINCYTO significantly improved survival rates compared to chemotherapy alone in pediatric patients with BCP-프라그마틱 슬롯사이트.

"Over the past decade, BLINCYTO has consistently expanded its indications, including 2015, 2020, and 2025," an Amgen Korea official said. "We are committed to supporting BCP-프라그마틱 슬롯사이트 patients in reaching a 100% cure rate throughout their treatment journey."

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