Hematologic Oncology

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

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.

The FDA granted fast track designation to rilzabrutinib for the treatment of patients with immune thrombocytopenia.

The survey highlighted the need for further research into the specific effects of ITP in individual patients so that these findings can be better integrated into the management of this patient population.

This study suggested that there is evidence, though low quality, that rituximab (Rituxan) may be a more effective second-line therapy than splenectomy for children with immune thrombocytopenia.

Patients with immune thrombocytopenia treated with rituximab (Rituxan), splenectomy, eltrombopag (Promacta), or romiplostim (Nplate) saw significant increases in platelet count with each of the 4 treatments.

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.”

Though this study did not determine the causality, it clearly demonstrated an association between atopy and immune thrombocytopenic purpura (ITP).

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.

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

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.

Mesoblast Limited announced that the FDA issued a complete response letter regarding its biologics license application for remestemcel-L to treat pediatric patients with SR-aGVHD after the ODAC voted 9:1 in favor of the available efficacy and data.

These findings suggest that rozanolixizumab has good potential as a treatment for this patient population.

Researchers indicated these study findings “could be a note of caution for transplant centers to not take for granted that the frozen product they have received will show perfect recovery once thawed.”

The supplemental biologics license application is seeking approval for the treatment of patients with light chain amyloidosis and is supported by results observed in the phase 3 ADROMEDA study.

This study is the first to show anti-GPIIbIIIa and anti-GPIbIX in the bone marrow of patients with immune thrombocytopenia.

The Oncologic Drugs Advisory Committee voted in favor of the available data supporting the efficacy of remestemcel-L in pediatric patients with steroid-refractory acute graft-versus-host disease.

The study is evaluating itolizumab in patients with severe acute graft-versus-host disease as a first-line treatment concomitant with standard of care.

The study is evaluating ruxolitinib in patients with refractory or steroid-dependent chronic graft-versus-host disease compared to best available therapy.

The trial evaluated zanubrutinib, a potent and selective BTK inhibitor, versus ibrutinib, a first generation BTK inhibitor, in patients with Waldenström macroglobulinemia.

In this study, neutrophil extracellular traps were found to prompt the lethal blood clots and inflammation that occur in some patients with COVID-19.

Results from the trial indicated that zanubrutinib was associated with a higher complete response or very good partial response rate and demonstrated clinically meaningful advances in safety and tolerability in patients with Waldenström macroglobulinemia.

The FDA is set to review a supplemental new drug application for ibrutinib in combination with rituximab for the treatment of Waldenström’s macroglobulinemia.

Though steroids currently remain the standard frontline treatment for patients with immune thrombocytopenia, second-line treatment options for this patient population are rapidly expanding.

A study presented at the AACR Virtual Annual Meeting II indicated that Hispanics are diagnosed with blood cancers at a significantly younger age than non-Hispanic white individuals.

Principia Biopharma announced positive data on the durability of response from an ongoing phase 1/2 trial of the investigational treatment in patients with immune thrombocytopenia.

The MD Anderson expert discussed the phase 3 trial – designed to evaluate frontline eprenetapopt in combination with azacytidine (Vidaza) in patients with TP53-mutant positive myelodysplastic syndrome (MDS) – that recently completed full enrollment.

These study findings indicated that primary hemostasis and bleeding are dynamic and more interdependent than platelet counts and bleeding in extremely preterm neonates with thrombocytopenia.

The trial compared zanubrutinib, a potent and selective BTK inhibitor, versus ibrutinib, a first generation BTK inhibitor, in patients with Waldenström macroglobulinemia.

The study evaluated the use of axicabtagene ciloleucel (axi-cel) in patients with relapsed or refractory indolent non-Hodgkin lymphoma.