EMA’s CHMP backs Sanofi’s Sarclisa for multiple myeloma approval

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a nod for the approval of Sanofi’s Sarclisa when used in combination with Velcade, Revlimid, and dexamethasone (VRd) for the treatment of newly diagnosed multiple myeloma (MM). This therapeutic regimen is particularly targeted at patients who are not candidates for autologous stem cell transplants.

This recommendation by the CHMP was influenced by data from the global Phase III IMROZ clinical trial. This trial assessed the effectiveness of Sarclisa in combination with VRd in improving progression-free survival compared to VRd alone. Sarclisa, which operates through mechanisms including apoptosis and immunomodulatory activity, has already received approval in over 50 countries for use in specific adult patients with relapsed or refractory MM.

The safety profile of Sarclisa combined with VRd was consistent with previous observations, with no new safety issues identified. Dietmar Berger, Sanofi's global head of development and chief medical officer, emphasized the significance of the CHMP’s positive opinion. He noted that this approval represents a significant advancement for those with newly diagnosed multiple myeloma who are ineligible for transplants, as effective first-line therapy could potentially improve their long-term outcomes.

Berger also highlighted the potential of this Sarclisa-based combination to become a new standard-of-care treatment for patients in the European Union, addressing a critical unmet need in the treatment of multiple myeloma and reinforcing Sarclisa’s potential as the preferred anti-CD38 therapy.

Sarclisa first received global approval from the Food and Drug Administration (FDA) in September for this particular indication, with the FDA granting it orphan drug exclusivity. Sanofi remains committed to advancing its clinical development program, which includes a variety of Phase II and Phase III trials exploring multiple potential indications for Sarclisa.

While awaiting the final decision from the EMA in the forthcoming months, Sanofi is also investigating a subcutaneous administration method for Sarclisa in clinical trials. However, it is important to note that the safety and efficacy of Sarclisa outside its currently approved indications and administration methods have not yet been evaluated by regulatory authorities.

In June 2020, the European Commission granted approval for Sarclisa to be used in the treatment of multiple myeloma, further solidifying its role in the therapeutic landscape for this challenging disease.