ODAC Votes Against Accelerated Approval for Selinexor

In an emotional discussion on Tuesday, February 26 at the FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting, committee members voted 8 to 5 to await the results of an ongoing randomized trial (BOSTON phase III trial) comparing bortezomib and dexamethasone with and without selinexor, instead of approving selinexor now based on the single-arm STORM trial results of selinexor plus dexamethasone.

Black Swan Project Tracking Early Disease

In this week’s Myeloma Minute, a new video gives an overview of the IMF Black Swan Research Initiative (BSRI). As we move into 2019, there are ambitious plans to accelerate the search for a cure, uncover the mysteries surrounding early disease onset, and focus on potential prevention strategies.

Understanding immune monitoring, and why global obesity is on the rise

Ever since the IMF launched the Black Swan Research Initiative (BSRI) in 2012 to find the pathway to a cure for multiple myeloma, the project has focused on achieving and documenting minimal residual disease (MRD), the lowest level of disease possible with currently available therapies. However, with both early disease (monoclonal gammopathy of undetermined significance, MGUS, and smoldering multiple myeloma, SMM) and after therapy, many patients can do well even with obvious residual disease. As the BSRI team is learning, MRD assessment is but one step to understanding how myeloma progresses. We can gain even further insight by examining the role of immune cells, the key factor in controlling residual disease.

Obesity, myeloma, and younger age of onset

The average age of first diagnosis of myeloma is 67. However, as reported in The New York Times, a new study shows that those born in 1985 (or later) had a 59 percent higher risk of developing myeloma versus individuals born in 1950 (or earlier). Adults in this study aged 25 to 49 had an increased risk of developing myeloma, and it was linked to the increased occurrence of obesity in this younger population. This is something quite new and unexpected. It is definitely a wake-up call about both the magnitude of the obesity epidemic in the U.S. and the potential for serious consequences.

Pages