The US Food and Drug Administration (FDA) has accepted for priority review Sanofi‘s supplemental Biologics Licence Application (sBLA) for Sarclisa (isatuximab) combination regimen to treat transplant-ineligible newly diagnosed multiple myeloma (NDMM) patients.

Sanofi is seeking approval for Sarclisa, a monoclonal antibody, in combination with bortezomib, lenalidomide and dexamethasone (VRd) to treat NDMM patients.

The US regulator is anticipated to announce a decision on the approval by 27 September 2024.

The sBLA application is supported by positive data from the randomised, global, multicentre, open-label Phase III IMROZ clinical trial of Sarclisa plus standard-of-care VRd.

The study enrolled 446 patients across 21 countries and 104 centres.

The trial met its primary endpoint at interim analysis for efficacy, showing statistically significant progression-free survival (PFS) improvement with Sarclisa regimen versus VRd alone.

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Sarclisa’s safety profile in the trial was in line with previously reported data.

The company is also seeking approval for Sarclisa from the European Union.

Sanofi Development global head and chief medical officer Dietmar Berger stated: “Despite recent advancements in multiple myeloma treatment, there remains a significant unmet need for new frontline therapies, particularly for transplant-ineligible patients who can face poor outcomes from the disease.

“The filing acceptances, as well as the FDA’s priority review designation, reinforce our confidence in Sarclisa as a potential best-in-class treatment and represent a critical step toward advancing this combination in a difficult-to-treat cancer.”

Sanofi recently collaborated with Formation Bio and OpenAI to harness AI to expedite drug development.

To streamline the process of bringing new medicines to patients, the companies will combine their data, software and tuned models to create purpose-built solutions across the development lifecycle of the drugs.