Amgen has submitted a supplemental Biologics License Application (sBLA) to the FDA for Blincyto (blinatumomab), their treatment for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Amgen’s sBLA submission will include data from Blincyto’s Phase 3 trial for B-cell precursor ALL along with new data of treatment for patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell ALL.
Blincyto was granted an accelerated approved by the FDA on December 3, 2014 for the treatment of Ph- relapsed or refractory B-cell precursor ALL, making it the first single-agent immunotherapy approved for this patient population.
In 2016, Amgen recieved a sBLA approval for Blincyto which included data supporting the treatment of pediatric patients with this type of ALL.
Phase 3 trial
In its Phase 3 randomized, active-controlled, open-label study involving 405 adult patients with Ph- relapsed or refractory B-cell precursor ALL, Blincyto demonstrated an almost two-fold increase in median overall survival (OS) compared to standard of care (SOC) which was chemotherapy.
Median OS was 7.7 months (95% CI: 5.6, 9.6) for Blincyto versus 4 months (95% CI: 2.9, 5.3) for SOC (stratified log-rank test p=.012; hazard ratio=0.71).
Blincyto is a CD19 antibody that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.
About acute lymphoblastic leukemia
Acute lymphoblastic leukemia (ALL) is a type of leukemia that starts from white blood cells in the bone marrow, the soft inner part of bones. It develops from cells called lymphocytes, a type of white blood cell central to the immune system, or from lymphoblasts, an immature type of lymphocyte.
ALL invades the blood and can spread throughout the body to other organs, such as the liver, spleen, and lymph nodes. But it does not normally produce tumors as do many types of cancer. It is an acute type of leukemia, which means it can progress quickly. Without treatment, it can be fatal within a few months.