Pfizer announced that its investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin received Breakthrough Therapy designation from the U.S. FDA for acute lymphoblastic leukemia (ALL). Inotuzumab ozogamicin is an ADC comprised of a monoclonal antibody (mAb) targeting CD22, a cell surface antigen expressed on approximately 90 percent of B-cell malignancies, linked to a cytotoxic agent. When inotuzumab ozogamicin binds to the CD22 antigen on malignant B-cells, it is internalized into the cell, where the cytotoxic agent calicheamicin is released to destroy the cell. ALL is an aggressive type of leukemia with high unmet need and a poor prognosis in adults. The current standard treatment is intensive, long-term chemotherapy.  In 2015, it is estimated that 6,250 cases of ALL will be diagnosed in the United States.

 

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http://www.pfizer.com/news/press-release/press-release-detail/pfizer_s_inotuzumab_ozogamicin_receives_fda_breakthrough_therapy_designation_for_acute_lymphoblastic_leukemia_all