Pharma Focus Asia

FDA Prioritizes Review of Sarclisa for Newly Diagnosed Multiple Myeloma Patients Excluded from Transplant Eligibility

Tuesday, May 28, 2024

The U.S. Food and Drug Administration (FDA) has given priority review status to the Supplemental Biologics License Application (sBLA) for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for treating newly diagnosed multiple myeloma patients ineligible for transplantation. This combination could potentially be the first of its kind, paving the way for a new treatment avenue for these patients. The FDA is expected to announce its decision on September 27, 2024. A similar submission is also being considered in the European Union (EU).

Sanofi, expressed confidence in Sarclisa's potential, stating that despite recent advancements, there's still a significant need for new first-line therapies, particularly for patients ineligible for transplantation. He emphasized that the regulatory acceptance of their submissions and the priority review designation from the FDA reinforce their belief in Sarclisa's potential to advance multiple myeloma treatment.

The application for supplemental license and EU approval is based on positive outcomes from the phase III clinical trial IMROZ. This trial showed a statistically significant improvement in progression-free survival among newly diagnosed multiple myeloma patients ineligible for transplantation who received Sarclisa in combination with VRd chemotherapy compared to those treated with VRd alone. Safety assessments indicated consistency with established safety profiles.

The IMROZ trial is the fourth phase III investigation of Sarclisa paired with VRd chemotherapy in newly diagnosed multiple myeloma patients ineligible for transplantation. The results of this trial will be presented at major congresses.

Priority review designation is given to drug applications with the potential to significantly advance the treatment of serious diseases.

The IMROZ trial enrolled 446 patients across multiple centers globally. Patients received Sarclisa in combination with VRd chemotherapy until disease progression or unacceptable adverse events.

Sarclisa is a monoclonal antibody targeting the CD38 receptor on multiple myeloma cells, inducing cytotoxic activities and immunomodulation.

Sarclisa has received approvals in multiple countries for various combinations in relapsed and refractory multiple myeloma patients. Its clinical development is ongoing in multiple myeloma and other cancers.

Multiple myeloma is a significant hematologic cancer with a high incidence rate and challenges in treatment and prognosis.



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