The FDA today approved blinatumomab for the treatment of Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, a rare form of ALL.
The FDA today approved blinatumomab (Blincyto) for the treatment of Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), a rare form of ALL.
Blincyto is the first approved drug that engages the body’s T-cells to destroy leukemia cells, according to a FDA press release.
The drug acts as a connector between a protein called CD19, which is found on the surface of most B-cell lymphoblasts, and CD3, a protein on T-cell lymphocytes, according to the FDA.
The immunotherapy is intended for patients whose cancer has returned after treatment or for patients who did not previously respond to treatment, the FDA stated.
A study suggested Blincyto showed a “substantial improvement” over available therapies in terms of treatment. The study involved 185 adults with Philadelphia chromosome-negative relapsed or refractory precursor B-cell ALL, and after at least 4 weeks of infusion, 32% of patients experienced complete remission for over 6 months.
“Immunotherapies, especially Blincyto with its unique mechanism of action, are particularly promising for patients with leukemia,” said Richard Pazdur, MD, director of the office of hematology and oncology products in the FDA’s center for drug evaluation and research, in a press release. “Recognizing the potential of this novel therapy, the FDA worked proactively with the sponsor under our breakthrough therapy designation program to facilitate the approval of this novel agent.”
By the end of the year, more than 6000 Americans will be diagnosed with the uncommon form of ALL, according to the National Cancer Institute.