CHMP Recommends Sarclisa Combo for Newly Diagnosed Multiple Myeloma Patients

CHMP’s Opinion on Sarclisa

Image Credits: Pharmaceutical Technology

Announcement

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommendation for the approval of Sarclisa, combining dexamethasone, bortezomib, and lenalidomide for the induction treatment of geriatric patients suffering from newly diagnosed multiple myeloma (NDMM) also suitable for autologous stem cell transplant. A final decision will be declared officially in the coming months. The recommendation was considered due to the GMMG-HD7 phase 3 study, which illustrated that Sarclisa with VRd induction treatment doubled the enhancement of prolonged PFS and MRD negativity benefit than VRd alone.

How does a Government Recommendation on the Medication Impact the Healthcare Market?

The involvement and attention to the development and improvement of patient care are a general concern. This general concern chose Sarclisa medication, learning about its effectiveness and potential to cure. The results finalized the qualification to expand the reach. This will lead to a solution for transplant-eligible, newly diagnosed multiple myeloma. The healthcare market seeks the new medications cum solution in the market to accelerate patient care.

GMMG-HD7

The CHMP’s opinion is also based on the part one results received from the two-part German-speaking myeloma multicenter group (GMMG)-HD7, a clinical study represented at the 2024 American Society of Hematology annual meeting & exposition. A first phase 3 study, GMMG-HD7, describes a deep and quick response with an anti-CD38-based induction in transplant-eligible (TE) NDMM patients. The high volume of patients with minimal residual disease (MRD) negativity benefits post-induction. Besides this, the progression-free survival (PFS) advantage from randomization despite maintenance therapy and consolidation.

Further, the data revealed the highest post-transplant and post-induction MRD negativity rates of CD38 monoclonal antibody with the help of VRd in TE NDMM. The results are linked to a growing body of clinical evidence and support the use of sarclisa, spotlighting the potential of sarclisa-VRd in transplantation. Currently, the Sarclisa has been accepted in three indications in the EU, in various lines of therapy in the elderly (adult) patients with refractory and/or relapsed (R/R) MM and NDMM, who are not qualified for transplantation.

Views and Statements

The global head of oncology, Olivier Nataf, said, “The CHMP’s recommendation signifies the progress towards our ambition and interest for Sarclisa. Sarclisa that identifies patient needs, meeting various myeloma care and advancing treatment for excellent outcomes at all stages of the dieases globally. If approved, this regimen will introduce a new induction option to provide transplantation (to eligible patients).”