Tag Archives: CD19

CD-19 CAR T-cell gets unanimous ODAC recommendation and Blincyto wins full FDA approval – managing cytokine release syndrome

This week, the FDA Oncology Drug Advisory Committee provided a unanimous recommendation to Novartis’ tisagenlecleucel, a CAR (chimeric antigen receptor) T-cell therapy directed against CD19 for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).  In addition, the FDA granted full approval to Amgen for Blincyto (blinatumomab), a bispecific monoclonal antibody that targets CD19, for indicated for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children. Blincyto received conditional approval in 2015 for this claim. Continue reading →

Bi-specific antibodies – matchmaking cancer and T-cells

Amgen reported encouraging data from a 189 patient phase 2 trial at this year’s ASCO meeting on blinatumomab in patients with Philadelphia Chromosome (9,22 translocation) negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL)  – see  http://ecancer.org/conference/514-asco-2014/video/2913/blinatumomab-shown-to-be-beneficial-in-relapsed-refractory-b-precursor-acute-lymphoblastic-leukaemia.php. Continue reading →