Hematology | Topics

Duvelisib Indication in Relapsed/Refractory Follicular Lymphoma Withdrawn in U.S. Market
December 06, 2021

A United States indication for duvelisib in previously treated relapsed/refractory follicular lymphoma has been voluntarily withdrawn by developer Secura Bio following an assessment of the drug and subsequent consultation with the FDA.

FDA Approves Rituximab Plus Chemo for Select Pediatric Hematologic Malignancies
December 03, 2021

The FDA has approved rituximab plus chemotherapy for previously untreated pediatric CD20-postive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, and mature B-cell acute leukemia following results from the phase 3 Inter-B-NHL Ritux 2010 study.

Following Type-B Meeting With FDA, Omidubicel Planned for BLA in Hematologic Malignancies
November 12, 2021

Cell therapy omidubicel, designed for patients with hematologic malignancies who are undergoing allogeneic stem cell transplant, will be submitted to the FDA for approval in 2022.

Artificial Intelligence–Supported Precision Medicine Platform Improves Treatment Outcomes in Hematologic Cancers
November 11, 2021

The single-cell functional precision medicine treatment, an artificial intelligence strategy helps to create therapies for patients with hematologic cancers.

Increased Mortality Risk Seen in Older Patients With B-Cell Malignancies Who Contracted the COVID-19 Virus
October 29, 2021

Older patients undergoing treatment for B-cell malignancies who contracted the COVID-19 virus were at an increased risk of death vs patients with other cancers under the age of 60 years.

FDA Issues Complete Response Letter For Narsoplimab as Treatment of HSCT–Associated Thrombotic Microangiopathy
October 20, 2021

The FDA issued a complete response letter to the company responsible for developing narsoplimab because of the inability to estimate treatment effects on patients receiving hematopoietic stem cell transplant–associated thrombotic microangiopathy.

Therapeutic Challenge Exists With Treating Accelerated Phase Myeloproliferative Neoplasms
October 16, 2021

There remains a therapeutic challenge with understanding and treating patients with accelerated myeloproliferative neoplasms.

CD19 CAR T CTX110 Yields Positive Results in B-Cell Malignancies in Ongoing Phase 1 Trial
October 13, 2021

Findings from the phase 1 CARBON trial indicated that patients with relapsed/refractory CD19-positive B-cell malignancies may benefit from CTX110 CAR T-cell therapy.

Late Mortality Risk Decreases Among Those Who Undergo Allogeneic Blood or Marrow Transplantation at Younger Age
October 12, 2021

Results from a cohort study found that the rate of late mortality has decreased over the last 40 years for patients who transplantation at a younger age or who received a bone marrow transplant.

Clinical Hold on Development of Rusfertide Removed by FDA
October 12, 2021

Clinical trials featuring rusfertide may resume dosing patients after the FDA lifted a full clinical hold on the therapy’s clinical studies.