- Blincyto (blinatumomab) is an immunotherapy-based oncology treatment that has now been approved by the FDA for the treatment of patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL).
- B-cell ALL is a rare form of ALL. Only about 6,000 people are diagnosed with condition each year. But it is also a rapidly growing and deadly form of cancer.
- After an expedited review process that yielded an approval five months ahead of the PDUFA date, Blincyto was approved based on demonstration of safety and effectiveness in a clinical study of 185 adults with B-cell ALL. At the end of the study, researchers found that 32.2% of patients had no evidence of the disease for 6.7 months.
Amgen hit all the right targets in terms of positioning Blincyto for approval ahead of the intended PDUFA date, which was originally slated for May 19, 2015.
The FDA granted Blincyto breakthrough therapy designation, priority review, and orphan product designation, because Amgen demonstrated that the drug could offer potential improvement over other therapies (and also because B-cell ALL is a rare disease).
Approval of Blincyto represents another step forward for immunotherapy. Furthermore, Blincyto is a first in class drug, in that it is the first FDA-approved medication that engages the body's T cells to destroy leukemia cells. This is truly a win for Amgen—and an even bigger win for B-cell ALL patients.