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In adults with PMBCL, KEYTRUDA 200 mg is administered as an intravenous infusion over 30 minutes every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
In pediatric patients with PMBCL, Keytruda is administered as an intravenous infusion over 30 minutes at a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.
The ICI treatment has found its place in the current practice, especially in the treatment of r/r cHL and PMBCL, out of hematologic diseases.
AE: Adverse event ALCL: Anaplastic cell lymphoma Allo-HSCT: Allogeneic hematopoietic stem-cell transplant APC: Antigen-presenting cell ASCT: Autologous stem-cell transplantation cHL: Classical Hodgkin lymphoma CR: Complete remission, CTLA-4: Cytotoxic T lymphocyte-associate protein-4 DLBCL: Diffuse large B cell lymphoma FL: Follicular lymphoma HL: Hodgkin lymphoma MCL: Mantle cell lymphoma NHL: Non-Hodgkin lymphoma OS: Overall survival PD: Progressive disease PD-1: Programmed cell death 1 receptor PDL-1: Programmed cell death 1 receptor ligand PFS: Progression-free survival PMBCL: Primary mediastinal B cell lymphoma PR: Partial response R/R: Resistant/relapsed TNFR: Tumor necrosis factor receptor Tregs: T regulatory cells.
A marketing authorization application has also been filed for axi-cel for the treatment of relapsed/refractory DLBCL, TFL and PMBCL with the European Medicines Agency, representing the first submission in Europe for a CAR T therapy.
These findings suggest the immunoglobulin-negative phenotype of PMBCL may be extrinsically regulated.
In pediatric patients with PMBCL, Keytruda is administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.
M2 PHARMA-August 28, 2018-Yescarta (Axicabtagene Ciloleucel) Receives European Marketing Authorization for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy
M2 PHARMA-July 6, 2018-Yescarta MAA for Treatment of DLBCL and PMBCL Garners Positive Opinion from European Medicines Agency
The FDA's approval of Yescarta is for treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma, and several more rare types including primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma or tFL).
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