With this nod, Sarclisa becomes the first anticancer treatment to be administered through an OBI. It is also the first MM therapy to offer the flexibility of both SC OBI and manual injection administration in the European Union (EU).<\/p>\n
This approval was expected after the EMA\u2019s Committee for Medicinal Products for Human Use (\u201cCHMP\u201d) issued a positive opinion recommending the approval of the SC formulation in March. Both the EC and CHMP decisions are supported by data from the phase III IRAKLIA study, which showed that treatment with Sarclisa SC was at least as effective as the IV version.<\/p>\n
Sanofi is also seeking approval for the SC version in the United States, where a regulatory filing supported by the IRAKLIA study is currently under FDA review. A final decision is expected next month.<\/p>\n
The SC formulation could provide a meaningful advantage over the IV version by reducing treatment administration time. Per Sanofi, the SC version can be delivered in approximately 13 minutes compared with up to several hours for the IV infusion. The shorter administration time may improve patient convenience, reduce the burden on healthcare providers and infusion centers, and potentially support broader adoption of the therapy.<\/p>\n
SNY\u2019s Stock Performance<\/p>\n
Year to date, shares of Sanofi have declined 7% against the industry<\/a>\u2019s 4.4% growth.<\/p>\n More on Sanofi\u2019s Sarclisa<\/p>\n Sarclisa is approved in the EU across four multiple myeloma indications. In combination with Bristol Myers’ (BMY Quick QuoteBMY<\/a> – Free Report<\/a>) Pomalyst (pomalidomide) and dexamethasone, the drug is approved for adults with relapsed or refractory MM who have received at least two prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor. Sarclisa is also approved in combination with Amgen\u2019s (AMGN Quick QuoteAMGN<\/a> – Free Report<\/a>) Kyprolis (carfilzomib) and dexamethasone for treating patients with relapsed\/refractory MM (RRMM) who have received at least one prior therapy.<\/p>\n The SNY drug is also approved in combination with Velcade (bortezomib), Bristol Myers\u2019 Revlimid and dexamethasone for adults with newly diagnosed MM who are ineligible for autologous stem cell transplant. This combination regimen is approved for adults with newly diagnosed MM who are eligible for autologous stem cell transplant.<\/p>\n Sarclisa is approved for similar indications in the United States.<\/p>\n Both Pomalyst and Revlimid are approved therapies in the MM space. Kyprolis is approved in combination with other drugs to treat certain RRMM patients.<\/p>\n SNY\u2019s Zacks Ranks<\/p>\n![\"Zacks](\"https:\/\/www.europesays.com\/europe\/wp-content\/uploads\/2026\/06\/164772.jpg\"\/)
Image Source: Zacks Investment Research<\/p>\n