Tag Archives: ALL

CAR T-cell more effective than standard of care in refractory Non-Hodgkin Lymphoma

The FDA granted approval of axicabtagene ciloleucel (YESCARTA) on October 25, 2017, two months following the approval of tisagenlecleucel (KYMRIAH) – both are anti-CD19-directed CAR T (chimeric antigen receptor T-cell) therapies that employ re-programmed autologous T-cells to fight cancer: Continue reading

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

Juno Advances CAR T-cell CAR017 and Halts CAR015 in Non-Hodgkin Lymphoma

Juno Therapeutics is developing Chimeric Antigen Receptor (CAR) T-cells directed against B-cell antigen CD19 for the treatment of patients with B-cell lymphomas. The company has elected to halt the development of JCAR015 for Acute Lymphoblastic Leukemia (ALL) and proceed with JCAR017 for relapsed/refractory diffuse large B-cell lymphoma (DLBCL), the most common form of Non-Hodgkin Lymphoma (NHL), due to the development of cerebral edema and subsequent death of several patients with ALL enrolled in its phase 2 ROCKET trial, which has been suspended. Continue reading

Lentiviral Vectors for Gene Transfection in CAR T-cell Therapy

Novartis entered into a $90 MM deal with Oxford Biomedica for use of its lentiviral vectors with its CAR (chimeric antigen receptor) modified T-cell product, CTL019, being developed with researchers at UPENN. 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