DOACs Cut Recurrent VTE in Adults With Cancer-Related Thrombosis
Direct oral anticoagulants reduce recurrent VTE events by 41 percent, with no significant increase in major bleeding, compared to dalteparin
Hematologic Disorders
New Dosing Regimen Approved for Gazyva in Follicular Lymphoma
For patients with follicular lymphoma who do not experience a grade 3 or higher IRR during Cycle 1, Gazyva may now be administered as a 90-minute infusion.
MPR Weekly Dose Podcast Episode 107
This week: millions of courses of a COVID-19 oral antiviral was provided to the US government for distribution throughout the country; There’s a draft guidance for novel nonopioid analgesics; Possible strangulation warning for enteral feeding tubes; A new treatment has been approved for cold agglutinin disease; And a treatment is under review for HFrEF.
Red Cross Says Blood Shortage Is Worst in a Decade
Organization has had to limit blood product distributions to hospitals
FDA: Safety Concerns With Lymphoma Drug Ukoniq
An initial review of data from the phase 3 UNITY trial in CLL patients showed the combination of Ukoniq and ublituximab was associated with increased risk of death compared with the control arm.
Vonvendi Approved for Severe Type 3 von Willebrand Disease
Results showed the median ABR for all bleeds was reduced by 54.7%.
Thrombosis, Thrombocytopenia Syndrome Up After Ad26.COV2.S
Reporting rates 3.83 per million vaccine doses for Ad26.COV2.S versus 0.00855 per million for mRNA-based vaccines
Incyte Withdraws Parsaclisib NDA for Follicular, Marginal Zone, and Mantle Cell Lymphomas
Parsaclisib is an investigational, highly selective, oral inhibitor of phosphatidylinositol 3-kinase delta.
Zydelig US Indications Withdrawn for Follicular Lymphoma, Small Lymphocytic Leukemia
Continued approval required further verification and description of clinical benefit in confirmatory trials.
FDA Extends Review Period for Gene Therapies for Beta-Thalassemia, Cerebral Adrenoleukodystrophy
The FDA extended the target dates for beti-cel and eli-cel to allow time to review additional clinical information for both applications.
