Sanofi Says FDA Approves Sarclisa for Treatment of Blood Cancer Patients

By Sabela Ojea

Sanofi said the Food and Drug Administration has approved Sarclisa as a first line combined treatment option for adult patients with newly diagnosed multiple myeloma who aren't eligible for autologous stem cell transplant.

The French pharmaceutical company said Sarclisa was approved in combination with bortezomib, lenalidomide and dexamethasone.

Multiple myeloma is a blood cancer that develops in plasma cells.

The FDA's decision marks the third approved indication for Sarclisa in the U.S. and the first approved indication in newly diagnosed patients, the company said.

The approval is based on data from the IMROZ phase 3 study recently presented at the American Society of Clinical Oncology 2024 annual meeting.

The FDA evaluated Sarclisa for this indication under priority review, Sanofi added, noting the treatment is also currently approved in more than 50 countries across two indications for the treatment of people with relapsed or refractory disease.

Write to Sabela Ojea at sabela.ojea@wsj.com

(END) Dow Jones Newswires

September 20, 2024 19:15 ET (23:15 GMT)

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