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Amgen Obtains FDA Breakthrough Therapy Designation for BiTE® Antibody Blinatumomab
The Breakthrough Designation Therapy for Investigational BiTE® Antibody Blinatumomab is designated for the treatment of Acute Lymphoblastic Leukemia.
The Breakthrough Therapy Designation was assigned due to significant clinical evidence obtained by the results of a Phase 2 trial of 189 adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab.
"There is a high unmet need for new medicines to treat relapsed and refractory ALL patients, who have very few treatment options," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The results from the Phase 2 trial evaluating blinatumomab in adult patients with relapsed or refractory ALL are encouraging and provide a strong basis for a regulatory filing later this year and potential approval in this serious disease."
Bispecific T cell Engager (BiTE®) technology is a groundbreaking investigational method that is intended to help engage the body's endogenous T cells to target malignant cells. Blinatumomab is an investigational BiTE® antibody designed to direct the body's cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas. According to Amgen, Blinatumomab is the first of the BiTE antibodies and they have already received orphan drug designation from the FDA for the treatment of ALL, chronic lymphocytic leukemia (CLL), hairy cell leukemia, prolymphocytic leukemia and indolent B cell lymphoma and from the European Medicines Agency for the treatment of indolent B cell lymphoma, ALL, CLL and mantle cell leukemia (MCL).
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