This approval, following a 12-0 vote by the ODAC, signifies a major step forward for myeloma treatment. The decision was based on data from over 12,000 patients and 20 trials, demonstrating the efficacy of MRD testing in various treatment settings. This change will expedite drug approval processes, benefiting patients and the myeloma community.
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This week's Ask Dr. Durie comes from a patient who has heard that MRD testing for myeloma had recently been approved by the FDA and asking me to explain about this. Well, this patient is correct in that on April the 12th, there was a meeting by ODAC, the Oncology Drug Advisory Committee, a branch of the FDA, a committee called together by the FDA, did have a 12-0 approval vote for the use of MRD testing, minimal residual disease testing, as an early endpoint for the accelerated approval of drugs in trials, both in the front line setting and at relapse. And so this was a major vote in support of the use of MRD testing.
To achieve this, the i2TEAMM, the Independent International Team for Endpoint Approval of MRD Multiple Myeloma, a team brought together under the International Myeloma Working Group, IMWG, and linked to the Black Swan Research Initiative, this team pulled together data from around 20 trials and the data from over 12,000 individual patients in whom MRD testing had been conducting. And the team pulled together all of this information and presented it to the FDA.
The information showed that there was enough in the front line transplant eligible as well as transplant ineligible and the relapse refractory setting, there's enough data to indicate that MRD testing can be used as a acceptable indicator for accelerated approval.
One of the questions was at what time should the testing be performed? Data were presented for both 12 months and nine months from the start of a particular line of therapy. And data were strong for both of those time points.
And so the bottom line is that based upon the 12-0 vote by the ODAC committee, MRD is now considered an acceptable endpoint, an early endpoint for the accelerated approval of a new therapy or a new combination. And what this means across the board is that this early decision at nine or 12 months is substantially earlier than the longer follow what normally required for progression-free survival, the length of the remission, which with modern therapies, with current immune therapies, for example, can be over five years.
So there is a tremendous advantage and the achievement of much more timely approval, which is an advantage for patients, an advantage for the pharma drug development teams and for the myeloma community as a whole.
Professor of Medicine, Hematologist/Oncologist, and Honoree MD at the University of Brussels, Dr. Brian G.M. Durie is a co-founder of the IMF.
