Sarclisa is Sanofi’s new oncology drug
… Sanofi earns FDA approval for oncology mAb Sarclisa


A new multiple myeloma therapy: Sarclisa


John G. Baresky

Sarclisa (isatuximab-irfc) is a new IV oncology product from Sanofi that is approved by the FDA for use in the treatment of adult patients with relapsed refractory multiple myeloma who have already received at least two prior therapies. Sarclisa is a monoclonal antibody (mAb) that binds to the CD38 receptor on multiple myeloma cells.

Sarclisa is FDA approved for treating multiple myeloma in adults

Multiple myeloma is a type of blood cancer in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply while producing an abnormal protein that pushes out other healthy blood cells from the bone marrow. Multiple myeloma can trigger an array of healthcare issues including bone and kidney problems, weakened immune systems and other medical conditions requiring advanced physician care.

Sarclisa’s promising clinical study results

In a leading study, Sarclisa plus Bristol-Myers Squibb’s (NYSE: BMY) Pomalyst ( pomalidomide) and steroid dexamethasone (pom-dex) lowered the risk of disease progression or death by 40% when compared with administering pom-dex by itself.

Sarclisa is dosed every week for the first four weeks and then every other week until a patient’s disease progresses or they can no longer take the medicine. The product is a welcome addition to the therapeutic options oncologists currently have to treat their multiple myeloma patients. Sanofi is exploring the effectiveness of Sarclisa in cervical, lung and skin cancers that may potentially be approved by the FDA following their review.

Sanofi is recommitting itself to the development of new oncology therapies

Sanofi is re-positioning itself in several areas and oncology is one healthcare category where it seeks to reinvigorate its market presence. As the therapies are more complex they require more investment and there is a greater risk involving clinical trial results and getting FDA and other regulatory agency approvals in other countries.

Sanofi in the news with acquisitions and spinoffs

Sanofi (NASDAQ: SNY) has been in the news lately for several large scale developments. Based in Paris, France and generating about $42 billion in annual sales. it reportedly is shopping its consumer product portfolio and is spinning off its drug ingredients business unit to form a new company. It closed out December 2019 by acquiring immuno-oncology company Synthorx for $2.5 billion.

The approval of Sarclisa is welcome news for Sanofi as it seeks to re-establish its competitive position in cancer drug development as part of its new global corporate strategy.

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