Sanofi’s application for its multiple myeloma treatment Sarclisa (isatuximab) has been accepted by the US Food and Drug Administration (FDA) for priority review.
The company is seeking approval for the use of Sarclisa in combination with Takeda’s Velcade (bortezomib), lenalidomide and dexamethasone (VRd) to treat patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).
Recognised as the second most common haematologic malignancy, multiple myeloma is a type of bone marrow cancer responsible for more than 180,000 new global diagnoses every year.
Dietmar Berger, chief medical officer and global head of development at Sanofi, said: “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.”
Already approved in more than 50 countries, including the US and EU, to treat patients with relapsed/refractory multiple melanoma after receiving prior therapy, Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma cells, inducing distinct antitumour activity.
The US regulators decision was based on positive results from the phase 3 IMROZ study evaluating the investigational use of Sarclisa in combination with standard-of-care VRd.
The study met its primary endpoint in December 2023, demonstrating statistically significant improvement in progression-free survival with Sarclisa in combination with VRd compared with VRd alone in transplant-ineligible patients with NDMM.
The treatment continues to be evaluated in several ongoing phase 3 clinical studies in combination with current standard treatments across MM and is also being investigated to treat other haematologic malignancies.
If approved for a third indication in multiple myeloma, Sarclisa would be the first anti-CD38 therapy in combination with VRd in newly diagnosed patients not eligible for transplant.
“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 towards advancing this combination in a difficult-to-treat cancer,” said Berger.
The FDA’s decision is expected by 27 September 2024 and a regulatory submission is also currently under review in the EU.