A highly effective four-drug combination could be emerging as a new standard of care for newly diagnosed myeloma patients who are not candidates (or ineligible) for stem cell transplantation. Multiple myeloma specialist Dr. Thierry Facon from Lille University Hospital and colleagues shared their findings at the ASCO 2024 conference in June.
The Phase 3 IMROZ study evaluated the efficacy and safety of adding isatuximab (Isa) to the standard bortezomib, lenalidomide, and dexamethasone (VRd) regimen.
The study concluded that the Isa-VRd combination significantly improved progression-free survival and response rates compared to the standard VRd regimen, offering new hope for better long-term disease management in transplant-ineligible patients.
Given the substantial benefits observed, Isa-VRd has the potential to become the new standard of care for transplant-ineligible newly diagnosed myeloma patients.
Even though this combination had more adverse effects, it was determined to be safe to use. Patients should work closely with their healthcare team to monitor and manage any side effects.
Multiple studies continue to evaluate isatuximab, potentially expanding its application across the multiple myeloma treatment spectrum.
On May 27, 2024, the U.S. Food and Drug Administration (FDA) accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of isatuximab (Sarclisa, Sanofi) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for treating patients with transplant-ineligible newly diagnosed multiple myeloma.
If approved, isatuximab would become the first anti-CD38 therapy used with standard-of-care VRd in this patient group, marking the third approved indication for isatuximab in multiple myeloma. The FDA's decision is expected by September 27, 2024. A similar regulatory submission is also under review in the European Union (EU).
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A highly effective four-drug combination could be emerging as a new standard of care for newly diagnosed myeloma patients who are not candidates (or ineligible) for stem cell transplantation. Multiple myeloma specialist Dr. Thierry Facon from Lille University Hospital and colleagues shared their findings at the ASCO 2024 conference in June.
The Phase 3 IMROZ study evaluated the efficacy and safety of adding isatuximab (Isa) to the standard bortezomib, lenalidomide, and dexamethasone (VRd) regimen.
The study concluded that the Isa-VRd combination significantly improved progression-free survival and response rates compared to the standard VRd regimen, offering new hope for better long-term disease management in transplant-ineligible patients.
Given the substantial benefits observed, Isa-VRd has the potential to become the new standard of care for transplant-ineligible newly diagnosed myeloma patients.
Even though this combination had more adverse effects, it was determined to be safe to use. Patients should work closely with their healthcare team to monitor and manage any side effects.
Multiple studies continue to evaluate isatuximab, potentially expanding its application across the multiple myeloma treatment spectrum.
On May 27, 2024, the U.S. Food and Drug Administration (FDA) accepted for Priority Review the supplemental Biologics License Application (sBLA) for the investigational use of isatuximab (Sarclisa, Sanofi) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for treating patients with transplant-ineligible newly diagnosed multiple myeloma.
If approved, isatuximab would become the first anti-CD38 therapy used with standard-of-care VRd in this patient group, marking the third approved indication for isatuximab in multiple myeloma. The FDA's decision is expected by September 27, 2024. A similar regulatory submission is also under review in the European Union (EU).
You can also actively participate in research by joining the HealthTree Cure Hub community! A platform that powers life-saving research.
If you are interested in participating in or finding a clinical trial, keep track of your labs and studies all in one place, you can create a free account and safely connect your records!
Sources:
about the author
Jimena Vicencio
Jimena is an International Medical Graduate and a member of the HealthTree Writing team. She has a passion for languages and is currently learning Japanese. In her free time, she loves playing with her cats. Jimena is also pursuing a bachelor's degree in journalism.
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