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.
Hematologic Disorders
Vonvendi Approved for Severe Type 3 von Willebrand Disease
Results showed the median ABR for all bleeds was reduced by 54.7%.
Zydelig US Indications Withdrawn for Follicular Lymphoma, Small Lymphocytic Leukemia
Continued approval required further verification and description of clinical benefit in confirmatory trials.
Durable Response Observed With Gene Therapy for Hemophilia A
The phase 3 GENEr8-1 study evaluated valoctocogene roxaparvovec in adults with severe hemophilia and residual FVIII levels less than or equal to 1 IU/dL.
Injectafer Approval Expanded to Pediatric Patients With Iron Deficiency Anemia
Injectafer is an iron replacement product.
Siklos Approval Expanded to Include Adults With Sickle Cell Anemia
The approval was based on data from the European Sickle Cell Disease Cohort study, which evaluated the efficacy and safety of Siklos in 1077 adults with sickle cell disease.
High Temperature Exposure Prompts Recall of Anticoagulant Med
Exposure to higher temperatures may have significantly impacted the efficacy of the recalled product.
Luspatercept Under Review for Nontransfusion Dependent Beta Thalassemia
The application is supported by data from the phase 2 BEYOND study.
FDA Unable to Approve Narsoplimab for HSCT-TMA Without More Data
Narsoplimab is a human monoclonal antibody that specifically targets mannan-binding lectin-associated serine protease-2.
Tecartus Approved for Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
The approval was based on data from the phase 1/2 ZUMA-3 trial which evaluated Tecartus in 71 adults with relapsed or refractory B-cell precursor ALL.
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