French pharmaceutical giant Sanofi announced on Monday that it had obtained approval from the European Commission for its cancer treatment Sarclisa in subcutaneous formulation, via a portable injector, to treat multiple myeloma, following a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
“ Sarclisa is the first cancer treatment in the EU to be administered via a portable injector and by manual (subcutaneous) injection, offering flexibility for administration in patients' homes or on an outpatient basis.Sanofi said in a statement.
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Approval from the U.S. Food and Drug Administration (FDA) is pending
“ With this newly approved option, we have the opportunity to reduce pressure on healthcare systems while placing greater flexibility and convenience at the heart of patient-centered care." explains Professor of Hematology at the Sorbonne, Mohamad Mohty, quoted in the press release.
This solution is currently being reviewed by regulatory authorities in several countries, including the United States, Japan and China, the pharmaceutical group said.
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In April, the US Food and Drug Administration (FDA) postponed its decision by three months, which is now expected on July 23, Sanofi indicated at the time.
Multiple myeloma is a form of plasma cell cancer caused by abnormal cell production within the plasma, which multiply and accumulate in the bone marrow, crowding out healthy cells and preventing them from functioning normally.
Since its launch in 2020, Sarclisa, a monoclonal antibody, has been approved in nearly 60 countries and prescribed to 70,000 patients worldwide.
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