FDA Approves Amgen's Blincyto for New Leukemia Use

Amgen’s Blincyto (blinatumomab) has recently received approval from the US Food and Drug Administration (FDA) for treating both adult and pediatric patients aged one month and older who have an aggressive type of blood cancer. This approval pertains specifically to patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) during the consolidation phase, irrespective of measurable residual disease (MRD) status.

Acute lymphoblastic leukemia (ALL) is a rapidly progressing blood cancer originating in the bone marrow, occasionally spreading to other body parts. Within the ALL spectrum, B-ALL is the predominant subtype, representing about 75% of adult cases. In the United States alone, over 6,500 new ALL cases were identified last year.

Blincyto is administered as an intravenous infusion and had already been sanctioned in the US for two other B-ALL treatment scenarios. This therapy functions as a bispecific T-cell engager (BiTE) immuno-oncology drug, specifically targeting CD19 surface antigens present on B cells.

The FDA’s endorsement of Blincyto for this new indication is grounded in the positive outcomes of the late-stage E1910 trial, which was spearheaded by the ECOG-ACRIN Cancer Research Group. The study demonstrated that Blincyto, when added to multiphase consolidation chemotherapy, offered significantly better overall survival (OS) rates compared to chemotherapy alone for patients with newly diagnosed Philadelphia chromosome-negative B-ALL.

Data from the E1910 trial revealed that the three-year OS rate was 84.8% for those who received the combination of Blincyto and chemotherapy, in contrast to 69% for the chemotherapy-only group. Additionally, with a median follow-up period of 4.5 years, the five-year OS stood at 82.4% for the Blincyto/chemotherapy cohort, compared to 62.5% for those who received only chemotherapy.

Jay Bradner, who serves as the executive vice president of research and development, as well as the chief scientific officer at Amgen, remarked, "Blincyto has provided significant benefits to thousands of B-ALL patients over the past decade. This latest approval for treating patients in the frontline consolidation phase, regardless of MRD status, will enable us to extend the reach of this transformative, first-in-class BiTE therapy to an even larger patient population."

This recent FDA approval of Blincyto follows closely on the heels of another significant milestone for Amgen. The company’s Bkemv (eculizumab-aeeb) was recently authorized as the first interchangeable biosimilar to AstraZeneca’s Soliris (eculizumab) for treating two rare diseases characterized by the disintegration of red blood cells. Additionally, Amgen received accelerated FDA approval last month for its immunotherapy drug Imdelltra (tarlatamab-dlle).