The Food and Drug Administration (FDA) of the United States has extended the target action date for its review of the biologics license application for Sarclisa in subcutaneous formulation by three months, in combination with approved standard therapeutic regimens for the treatment of patients with multiple myeloma in all currently approved U.S. indications for the intravenous formulation.
The company specified that the revised target action date is July 23. The company also stated its commitment to work closely with the FDA to bring this new advancement to patients and healthcare professionals as quickly as possible. If approved, Sarclisa would be the first anticancer treatment to be administered by a portable injector.
On March 26, 2026, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the approval of Sarclisa SC for administration via both portable injector and manual injection for the treatment of patients with MM in all currently approved indications and combinations for the IV formulation of Sarclisa in the EU. A final decision is expected in the coming months.
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