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The sNDA submission for ruxolitinib to treat steroid-refractory chronic graft-versus-host disease in adult and pediatric patients 12 years and older was based on the phase 3 REACH3 study, which is assessing the safety and efficacy of ruxolitinib compared with best available therapy.

FDA Grants Priority Review to sNDA for Ruxolitinib to Treat Steroid-Refractory cGVHD

A promising approach to treating newly diagnosed acute graft-versus-host disease emerges, based on data regarding the use of the humanized IgG1 monoclonal antibody itolizumab.


Newly Diagnosed Acute GVHD Shows Benefit With Itolizumab Use

A supplemental new drug application submission was primarily based on safety and efficacy data from the global phase 3 ASPEN trial of zanubrutinib compared with ibrutinib for the treatment of Waldenström macroglobulinemia.

FDA Accepts sNDA for Zanubrutinib for Treatment of Waldenström Macroglobulinemia 

Findings from a poster presentation at the 2021 Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR suggest the feasibility of successful vaccinations against coronaviruses in patients with hematologic malignancies following stem cell transplant.

Effective T-Cell Immunity Against Various Coronaviruses Is Possible in Stem Cell Transplant Recipients

A new rituximab biosimilar from Amgen is now FDA approved, providing more treatment options to patients with certain hematologic cancers.

FDA Approves Biosimilar to Rituximab as Treatment for Hematologic Malignancies

Patients with hematologic malignancies were found to be at increased risk for significant morbidity and mortality from COVID-19, and the risk of death appeared to be greatest in those who were older, had more severe infection, a poorer prognosis, or who decided to forego intensive treatment.

Hematologic Cancers Bear Increased Risk for Adverse COVID-19 Outcomes

According to researchers, this study suggests “that the improvements in QOL and mood experienced by caregivers assigned to BMT-CARE are, in part, explained by an acquisition of effective coping skills and confidence in their ability to provide care for their loved one.”

Study of BMT-CARE Finds Coping, Self-Efficacy to Improve QOL, Mood in Caregivers of HSCT Recipients

Patients with hematologic disease and a symptomatic COVID-19 infection were found to have a significantly worse prognosis than patients who were nonhematologic with COVID-19.

Patients with Hematologic Disease and Symptomatic COVID-19 Infection See Worse Prognosis

The FDA granted breakthrough therapy designation to IMGN632 for the treatment of patients with relapsed or refractory blastic plasymacytoid dendritic cell neoplasm.

FDA Grants Breakthrough Therapy Designation to IMGN632 for BPDCN

The study found that high levels of sustained factor VIII activity, which followed a normalization period after BIVV001 administration, might offer better protection against all types of bleeding and a longer interval between administration of the product in this patient population.

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