Blinatumomab, a BITE antibody, has received FDA priority review designation in acute lymphoblastic leukemia
The FDA ( Food and Drug Administration ) has accepted for review the Biologics License Application ( BLA ) for the investigational bispecific T cell engager ( BiTE ) antibody construct, Blinatumomab.
The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia ( ALL ), a rapidly progressing cancer of the blood and bone marrow.
As part of the acceptance, the FDA granted Blinatumomab priority review.
A Marketing Authorization Application ( MAA ) has also been submitted to the European Medicines Agency ( EMA ) via the centralized procedure for approval to market Blinatumomab for the treatment of adults with Ph- relapsed/refractory B-precursor acute lymphoblastic leukemia.
The submissions include data from a Phase 2 trial of adult patients with Ph- relapsed/refractory B-precursor acute lymphoblastic leukemia treated with Blinatumomab, which met its primary endpoint.
According to the FDA, priority review designation is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.
A priority review designation will set a goal date for taking action on an application within six months of receipt.
Acute lymphoblastic leukemia is an aggressive cancer of the blood and bone marrow, the spongy tissue inside bones where blood cells are made. The disease progresses rapidly and affects immature blood cells. Worldwide, acute lymphoblastic leukemia accounts for more than 12% of leukemia.
Of the 42,000 people diagnosed worldwide, 31,000 will die from the disease. Patients with acute lymphoblastic leukemia have abnormal lymphocytes that crowd out healthy white blood cells, red blood cells and platelets, leading to infection, anemia ( fatigue ), easy bleeding and other serious side effects.
In the U.S., more than 6,000 cases of acute lymphoblastic leukemia will be diagnosed in 2014, and in the European Union, it is estimated that more than 7,000 cases of acute lymphoblastic leukemia are diagnosed each year.
In adult patients with relapsed or refractory acute lymphoblastic leukemia, median overall survival is just 3 to 5 months.
Bispecific T cell engager ( BiTE ) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body's immune system to detect and target malignant cells.
The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells to cancer cells.
BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die ( apoptosis ). ( Xagena )
Source: Amgen, 2014