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ICML 2025 | The FDA approval of tafasitamab with R-squared for R/R follicular lymphoma
On June 18, 2025, the Food and Drug Administration (FDA) approved tafasitamab in combination with lenalidomide and rituximab (R-squared) for adult patients with relapsed/refractory (R/R) follicular lymphoma (FL). In this interview, Tycel Phillips, MD, City of Hope, Duarte, CA, comments on the approval and highlights the potential of this combination approach to replace R-squared for the treatment of patients who are heavily pre-treated or relapse early following their prior line of therapy. This interview took place during the 18th International Conference on Malignant Lymphoma (18-ICML) in Lugano, Switzerland.
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Transcript
As you know the AUGMENT study with lenalidomide-rituximab was really game-changing and sort of establishing that regimen as, at least in the US, as the preferred standard of care in the second-line space. It’s sort of been entrenched there for the last several years. I mean some issues obviously the patients enrolled in that study cannot be relapsed or refractory to single-agent rituximab given that the compared arm in AUGMENT was rituximab...
As you know the AUGMENT study with lenalidomide-rituximab was really game-changing and sort of establishing that regimen as, at least in the US, as the preferred standard of care in the second-line space. It’s sort of been entrenched there for the last several years. I mean some issues obviously the patients enrolled in that study cannot be relapsed or refractory to single-agent rituximab given that the compared arm in AUGMENT was rituximab. With the tafasitamab R-squared study, I mean obviously they’re comparing to R-squared, the initial publication demonstrated an improvement in progression-free survival and duration of response with the addition of tafasitamab. And I think the most impressive part of this was it was in a more heavily pre-treated and sort of riskier patient population than what we originally saw in AUGMENT. And so as we move forward, given the safety profile of tafasitamab and then we already know we have community uptake of tafasitamab-R in the large cell lymphoma space, I would anticipate that this will likely lead to an uptick in sort of greater utilization of this regimen as a replacement for lenalidomide-rituximab in this patient space. Now how long this regimen will stay maybe stay as maybe the preferred option in this space will likely depend on a lot of these other ongoing clinical trials that are coming out and I will I would say the only really negative to the tafasitamab-lenalidomide-rituximab combination is the, you know, maybe some cumbersome start to getting tafasitamab in patients, and obviously the extra visits that will come in between as tafasitamab is given, obviously every two weeks. I mean, so that will require more patient visits, more patient-facing, and obviously time in infusion chair. But especially in a patient who basically is maybe an early relapsing patient or a patient that is heavily pre-treated, this will be a very good option to hopefully get a more durable response in this patient space.
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