HEMATOLOGY

The phase 3 REACH3 trial of ruxolitinib in patients with chronic graft-versus-host disease with an inadequate response to corticosteroids demonstrated significantly higher overall response rate, a substantially greater improvement in failure-free survival, and greater symptom improvement compared with best available therapy.

The FDA accepted the New Drug Application from belumosudil and granted it a Priority Review designation for the treatment of patients with chronic graft-versus-host disease. The Prescription Drug User Fee Act target action date has been set to May 30, 2021.

Agents with novel mechanisms of action distinct from available ATP-competitive tyrosine kinase inhibitors have been tested in patients with previously treated, Philadelphia chromosome–positive chronic myeloid leukemia and offer promise to facilitate deeper remissions.

In an interview with Targeted Oncology during the Association for Molecular Pathology 2020 Annual Meeting, Rachel Sparks, MD, discussed the findings observed in hematologic malignancies with the use of a new RNA-based NGS assay.

The FDA has granted a Fast Track designation to rilzabrutinib, an oral investigational Bruton’s tyrosine kinase inhibitor, for the treatment of immune thrombocytopenia. The drug was previously granted Orphan Drug designation for this indication.

Routine testing for the presence of TP53 mutations in myeloid neoplasms by sequencing will become an important part of routine care as TP53-targeting agents become available, according to a poster presented at the Association for Molecular Pathology 2020 Annual Meeting and Expo.

Brain A. Jonas, MD, discusses the future of treatment for older patients with acute myeloid leukemia, now that the FDA has granted approval to azacitidine plus venetoclax for patients aged 75 years or older.

Nirav N. Shah, MD, discusses bispecific anti-CD20 and anti-CD19 chimeric antigen receptor T cells in a phase 1 dose escalation and expansion trial for relapsed B cell malignancies.

In an interview with Targeted Oncology following the announcement of the FDA approval of azacitidine plus venetoclax in older patients with acute myeloid leukemia, Brian Jonas, MD, provided insight on the VILAE-A study results. He also gave expert advice on how to approach treating older patients with acute myeloid leukemia in every day practice.

A key opinion leader provides insight into recent data updates from ongoing trials studying the management of GvHD with promising regimens. 

Outcomes for patients with myelodysplastic syndrome range from a median of 5.3 years in the lower-risk population to 8.4 months among patient with very high-risk disease. These outcomes are changing as novel therapies for the lower-risk population enter the treatment landscape.

There are several indications for the use of allo-SCT in adults. With the implementation of targeted therapies, these are continuously changing.

Guillermo Garcia-Manero, MD, discusses how the recently approved combination regimen of decitabine and cedazuridine fits into the treatment landscape for patients with myelodysplastic syndromes.

Two phase 3 clinical trials demonstrated consistent safety findings with the expected safety profile of guadecitabine as treatment of 2 patient populations, including patients with previously treated acute myeloid leukemia in ASTRAL-2 and patients with previously treated myelodysplastic syndrome or chronic myelomonocytic leukemia in ASTRAL-3.

Omidubicel as treatment of patients with high-risk hematologic malignancies induced rapid platelet engraftment and a reduction in the number of infections and hospitalizations, meeting all 3 secondary end points of a phase 3 clinical trial.

The FDA granted a Breakthrough Therapy designation to IMGN632 as treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasms.

The FDA issued a Complete Response Letter to remestemcel-L for the treatment of pediatric patients with steroid-refractory acute-graft-versus-host disease.

Arturo Loaiza-Bonilla, MD, MSEd, FACP ascended to the presidency of the Pennsylvania Society of Oncology, albeit virtually, during the society’s Annual Scientific Conference held via ZOOM on September 25.