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CHMP recommends EU approval for Sanofi's subcutaneous Sarclisa with portable injector for multiple myeloma.

Market News
27 Mar 2026
Sanofi
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Bullish
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The European Medicines Agency's CHMP has recommended approval of Sanofi's subcutaneous formulation of Sarclisa, administered via a portable on-body injector, for treating multiple myeloma in the EU. This new delivery method offers comparable efficacy and safety to the intravenous form and is the first cancer treatment in the EU to be available both as a subcutaneous injection via an on-body injector and manual injection. The recommendation is based on positive results from multiple clinical trials demonstrating non-inferiority and patient preference for the new method. A final regulatory decision is expected in the coming months, potentially improving treatment convenience and patient experience in multiple myeloma care.

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