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IMS 2024 | MRD as an early endpoint for accelerated approval: a success story
In this video, Ola Landgren, MD, PhD, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, discusses a presentation that he gave at the International Myeloma Society (IMS) Annual Meeting in which he shared the story of how measurable residual disease (MRD) was accepted as an endpoint for accelerated drug approval in multiple myeloma (MM). Prof. Landgren provides insight into the lengthy process he and his collaborators undertook to make this story a success. This interview took place at the 21st International Myeloma Society (IMS) Annual Meeting, held in Rio de Janeiro, Brazil.
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Transcript
At the IMS meeting in Rio de Janeiro, I was part of the presentation on MRD. That was a reflection of all the work we have done for almost 15 years. I started my work in 2009 at the NIH as an interagency collaboration with the FDA and the National Heart, Lung and Blood Institute. And we formed a group from the NIH that moved forward and we shared a lot of the results with academia and patient organizations...
At the IMS meeting in Rio de Janeiro, I was part of the presentation on MRD. That was a reflection of all the work we have done for almost 15 years. I started my work in 2009 at the NIH as an interagency collaboration with the FDA and the National Heart, Lung and Blood Institute. And we formed a group from the NIH that moved forward and we shared a lot of the results with academia and patient organizations. We continue working for all these years and we gathered all the data sets for all the randomized clinical trials both newly diagnosed and relapsed patients. We call this the evidence meta-analysis and we worked with the FDA for all these years. I had filed an IND, which is the same type of application a drug company would use when they file for a new drug to have it reviewed by the FDA. And after all these years, after all these negotiations with the FDA in January of 2024, we were formally told that the ODAC committee, the Oncology Drug Advisory Committee, that the FDA uses for drug companies when they have the data for new drugs, that committee was going to review MRD as an endpoint. And that never happened before in any other cancer. So I was the first presenter there and I presented the evidence meta-analysis and we show a very strong case in favor of MRD as an early endpoint for accelerated approval in multiple myeloma. So here at IMS we talked about that. There was also the I2 team that had also worked. They started their work a few years after us and then we worked in parallel and we joined back in early 24 sharing our results with each other because both the groups were going to ODAC and we wanted to make sure that was a very consistent message so the ODAC committee would not be confused. So that also was part of the story how you can work as two parallel teams, so you could say it’s sort of you compete a little bit with your friends, but at the end it’s all about working together and doing it for the greater good and we work for the patients. So, we help each other in the end, there were some flaws in some of the analysis we shared our analysis plan and it could be corrected and we could go together and give a very strong case. And that sort of was the bottom line of the IMS presentation here to share all the work and how that led to 12-0 in favor of MRD at ODAC.
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