- Amgen is going after a new indication for Blincyto (blinatumomab)---Philadelphia chromosome-positive (Ph+) B-cell precursor acute lymphoblastic leukemia (ALL).
- It is currently approved for Philadelphia chromosome-negative (Ph-) B-cell precursor acute lymphoblastic leukemia (ALL)---an indication which it received in November 2014.
- Upon approval, Blincyto became the first approved drug that uses the body's T-cells to destroy leukemia cells.
Blincyto's approval in November 2014 was based on strong data showing that 32% of treated patients with Ph- B-cell precursor ALL had complete remission for 6.7 months. The data was so strong that Blincyto was granted priority review and breakthrough therapy designation. Based on the preliminary phase II results of Blincyto in patients with the positive form of this disease, it seems that a priority review may be forthcoming. In trials, a "clinically meaningful" number of patients had complete remission.
While this bodes well, the data will have to be solid to justify the cost. Blincyto costs $178,000 for two treatments---the number of treatments that is intended to induce complete remission.