FDA Approves Blinatumomab for Relapsed or Refractory B-cell Precursor Acute

FDA Approves Blinatumomab for Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

On December 3, 2014, the U. S. Food and Drug Administration granted accelerated approval for BLINCYTOTM (blinatumomab) for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Acute lymphoblastic lymphoma (ALL) is a fast-growing cancer of the white blood cells. Relapsed/refractory ALL in adults has a dismal prognosis, with only 3540 percent of patients reaching a remission and a median overall survival of 46 months. Relapsed ALL is currently managed with stem cell transplantation and chemotherapy.

BLINCYTOTM is a bispecific CD19-directed CD3 T-cell engager that activates a patients T cells when it binds to the CD19-expressing target cell.  Activation of the T cells in the immune system results in release of inflammatory cytokines that fight the cancer.

BLINCYTOTM approval was based on the achievement of durable complete remission (CR) and response with a reduction in minimal residual disease (MRD) to less than 10-4 in a multicenter single-arm trial that enrolled 185 patients with ALL.  In this trial BLINCYTOTM was administered by continuous infusion for 4 weeks of a 6-week cycle and one to two cycles were used for induction and three cycles for consolidation.  In this study 32% of patients attained a CR with 2 cycles of treatment and the response lasted and average of 6.7 months.

Safety was evaluated and reported in 212 patients who treated with BLINCYTOTM.  The most common adverse reactions were fever (62%), headache (36%), peripheral edema (25%), febrile neutropenia (25%), nausea (25%), low potassium (23%), rash (21%), tremor (20%), and constipation (20%).  Neurological toxicity occurred in approximately 50% of patients and was a frequent reason for interruption of therapy.  Cytokine release syndrome was reported in 11% of the patients including both life-threatening and fatal events.

BLINCYTOTM represents a new and novel treatment option for patients battling ALL. Additional clinical trials will be performed with BLINCYTOTM alone or in combination with other anti-ALL therapies in order to determine how best to improve treatment of ALL.

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