We are positive on Juno's 10-year deal with Celgene for the global development and commercialization of immunotherapies. Further, the candidate was granted Priority Medicines (PRIME) eligibility for r/r DLBCL by the European Medicines Agency. Recently, Juno and Celgene Corporation CELG also initiated a phase Ib PLATFORM study, evaluating the combination of JCAR017 with AstraZeneca’s AZN Imfinzi (durvalumab), for treatment of patients with relapsed/refractory (r/r) NHL.Īdditionally, both Juno and Celgene announced that the FDA has granted Breakthrough Therapy designation to JCAR017, for the treatment of r/r aggressive large B-cell NHL including diffuse large B-cell lymphoma (DLBCL) and Primary Mediastinal B-cell Lymphoma (PMBCL).
#Juno therapeutics license
The company plans to bring JCAR017 to the market for NHL by the end of 2018 with biologics license application (BLA) expected to be filed in the second half of the same year. Juno reported promising additional data from the pivotal study including patients with DLBCL. Steroids: Therapeutic doses of corticosteroids are prohibited within 7 days prior to leukapheresis.JCAR017 is presently undergoing a phase I pivotal TRANSCEND study for non-Hodgkin lymphoma (NHL) including those with diffuse large B cell lymphoma (DLBCL), follicular lymphoma grade 3B or mantle cell lymphoma (MCL).History of treatment with a murine-derived biological product other than blinatumomab unless subject has been shown to be negative for human-anti-mouse-antibodies (HAMA) prior to or during screening.Participation in an investigational research study using an investigational agent within 30 days of screening.History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease.Active central nervous system (CNS) involvement by malignancy (defined as CNS-3 per National Comprehensive Cancer Network guidelines).Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening.Systemic fungal, bacterial, viral, or other infection that is not controlled, at the time of screening.Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening.Prior treatment with any gene therapy product.Prior malignancy, unless treated with curative intent and with no evidence of active disease present for > 5 years before screening.Burkitt's lymphoma/leukemia or chronic myelogenous leukemia lymphoid blast crisis (p210 BCR-ABL+).Concomitant genetic syndrome or other known bone marrow failure syndrome.
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