European Commission Approves Selinexor Plus Dexamethasone for Relapsed/Refractory Myeloma
Selinexor, in combination with dexamethasone, has been granted conditional marketing authorization by the European Commission (EC) for the treatment of adult patients with multiple...
FDA Approves Isatuximab-irfc Combination for Relapsed/Refractory Myeloma
Isatuximab-irfc, in combination with carfilzomib and dexamethasone (Isa-Kd), was approved by the U.S. Food and Drug Administration (FDA) on March 31, 2021 for the...
Countries Restrict AstraZeneca Vaccine for Younger Adults
Amid concerns over clotting risks, German and Canadian health officials have restricted usage of the AstraZeneca COVID-19 vaccine in people under the age of...
Investigation Finds Hemophilia Gene Therapy Likely Did Not Cause Hepatocellular Carcinoma
An investigation found that etranacogene dezaparvovec was unlikely to have caused a case of hepatocellular carcinoma (HCC) in a participant of the HOPE-B trial,...
Daunorubicin and Cytarabine Combination Approved for Pediatric Secondary AML
The U.S. Food and Drug Administration (FDA) has approved a revised label for liposomal daunorubicin and cytarabine, CPX 351, to include a new indication...
First CRISPR Trial for Patients with Severe Sickle Cell Disease to Begin
Scientists at the University of California (UC) Berkeley, the University of California San Francisco (UCSF), and the University of California Los Angeles (UCLA) have...
FDA Deputy Commissioner and CIO Amy Abernethy Resigns
Amy Abernethy, MD, PhD, has announced that she plans to resign from her roles as principal deputy commissioner and acting chief information officer at...
FDA Approves Idecabtagene Vicleucel for Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has approved idecabtagene vicleucel (ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell...
AstraZeneca COVID-19 Vaccine Data Highlight Safety Monitoring Boards’ Role in Clinical Trials
Confusion over AstraZeneca’s COVID-19 vaccine trial data recently arose when the data and safety monitoring boards (DSMBs) overseeing the trial took a public stand...
Does Elotuzumab Improve PFS in High-Risk Myeloma?
The addition of the anti-SLAMF7 antibody elotuzumab to lenalidomide, bortezomib, and dexamethasone (RVd) induction and maintenance did not improve outcomes for patients with previously...