In this week’s video, IMF Chairman of the Board Dr. Brian G.M. Durie covers the potential FDA approvals of such agents as belantamab mafodotin, bb2121, a new isatuximab combination, a new Kyprolis® combination, melflufen, and venetoclax.

BOTTOM LINE:
Several new drugs and combination therapies for relapsed and refractory myeloma patients are expected to be approved by the FDA in 2020.

Have a question? Submit it to AskDrDurie@myeloma.org

IMF Chairman and Co-Founder Brian G.M. Durie, MD welcomes your questions about the latest myeloma treatments, research, controversies and quality of life issues. If you have a question you think might be of interest to the myeloma community, please send to askdrdurie@myeloma.org!

For questions of a specific personal nature, please call the IMF InfoLine coordinators at 800.452.2873 or email them at infoline@myeloma.org

Transcript:

This week’s “Ask Dr. Durie” actually comes from a number of patients who are anxious about what new options will be available for them. And these are patients who have gone through multiple responses and relapses and are looking for new options to be available later this year and into 2020.

And so, what I’d like to do today is just summarize what our expectations are for possible FDA drug approvals in 2020. So, first of all, there are a couple of agents that almost certainly will be approved by the FDA early in the new year. The first one is a monoclonal antibody-drug conjugate GSK antibody, which has shown excellent results in the relapse setting. This is an anti-BCMA monoclonal antibody.

In addition, what has been very much in the news, the bb2121 CAR T-cell therapy, which has been showing very promising results in the relapse setting. And although this is a much more complicated and expensive therapy requiring several weeks of manufacturing to engineer those T cells to target the patient’s BCMA positive myeloma cells. It is expected that, with the very positive trial results, this will move forward with an approval in the relapse/refractory setting in 2020.

There are also some drug combinations which are coming out of successful trials. And these combinations will likely be approved. The first one is a combination of isatuximab, which is a new CD38 monoclonal antibody, combined with pomalidomide and dex. And then, the second one is coming from a trial called the CANDOR trial, in which carfilzomib is combined with daratumumab and dex. And this is also likely to achieve FDA approval

There are a variety of other agents which are moving through trials but are probably not quite ready for approval yet. These include Venetoclax, which is an anti-Bcl-2 inhibitor. This is an agent where there were some difficulties with a trial called the “BELLINI” trial, where in combination there were some added toxicities. However, this is a drug which targets patients with the translocation (11;14), and new trials focusing just on this type of patient are now ongoing and are likely to be quite promising.

Other agents are a type of melphalan, which is activated locally in the tissues. This is called Melflufen. And, this has shown some promising results, so, we hope that that can move forward. And there are a variety of other drugs which may move forward a little bit more slowly moving into 2020.

So, these are really exciting times, and the BOTTOM LINE is that there really are quite a number of agents which will be broadly available hopefully with FDA approval in 2020. And this means that there will be the broad access which is needed so that patients all across the country will be able to get these exciting new therapies.


Image of Dr. Brian G.M. DurieDr. Brian G.M. Durie founded and now serves as Chairman of the International Myeloma Foundation and serves on its Scientific Advisory Board. Additionally, he is Chairman of the IMF's International Myeloma Working Group, a consortium of nearly 200 myeloma experts from around the world. Dr. Durie also leads the IMF’s Black Swan Research Initiative®.

 

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