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Sanofi receives US approval for drug against multiple myeloma in newly diagnosed patients

Article 1 of 2 The logo of French drugmaker Sanofi is seen at the Sanofi Genzyme Polyclonals in Lyon, France, September 30, 2023. REUTERS/Gonzalo Fuentes/File Photo

[1/2]The logo of French drugmaker Sanofi is seen at the Sanofi Genzyme Polyclonals in Lyon, France, September 30, 2023. REUTERS/Gonzalo Fuentes/File Photo Purchase Licensing rightopens new tab
September 20 – The U.S. Food and Drug Administration announced on Friday that it had approved the use of a drug combination together with Sanofi's (SASY.PA).opens new tab Sarclisa infusion as a treatment for certain types of patients with newly diagnosed multiple myeloma.

Sarclisa was previously approved as a replacement therapy for certain cases of multiple myeloma when standard treatments have failed.

The French pharmaceutical group, a leader in anti-inflammatory drugs, has underlined its commitment to developing cancer drugs, even after a once-promising breast cancer drug candidate flopped in 2022.

The FDA approval allows the treatment plan to be used in patients who are not candidates for autologous stem cell transplantation, another treatment option for multiple myeloma.

In a late-stage study, a specific treatment regimen containing Sarclisa reduced the risk of disease progression or death by 40% compared with treatment without Sarclisa.

The study was conducted on patients who were not eligible for autologous stem cell transplantation, which uses the patient's healthy blood cells to restore bone marrow function.

In May, the drug received priority review status from the FDA.

Sanofi plans to continue developing blood cancer drugs known as anti-CD38, including Sarclisa, despite GenMab (GMAB.CO).opens new tab and Johnson & Johnson (JNJ.N)opens new tab strong position with Darzalex in the same class.

Sarclisa generated revenue of 227 million euros (253.40 million US dollars) in the first half of the year. Analysts expect Sarclisa's annual revenue to be around 800 to 900 million euros by 2030, according to LSEG data.

(1 US dollar = 0.8958 euros)

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Reporting by Ludwig Burger, Bhanvi Satija and Puyaan Singh in Bengaluru; Editing by Krishna Chandra Eluri

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