Company: Sanofi (EURONEXT: SAN; Nasdaq: SNY)
\nEvent Type: FDA approval \u2014 subcutaneous formulation, ahead of the July 23 PDUFA
\nModality: Anti-CD38 monoclonal antibody, subcutaneous \u2014 delivered via CirCLIQ on-body injector (Enable Injections enFuse platform) and manual SC
\nTarget: CD38
\nIndication: Multiple myeloma \u2014 all currently approved Sarclisa IV indications (NDMM transplant-ineligible; R\/R MM combinations)<\/p>\n
Summary: The FDA approved subcutaneous Sarclisa (isatuximab-irfc) Escena across all existing Sarclisa IV indications in multiple myeloma. It is the first anticancer treatment administered via an on-body injector, and the first myeloma therapy available by both SC on-body injector and manual SC administration in the US. Approval was supported by the pivotal IRAKLIA Phase 3 non-inferiority study: Sarclisa SC-Pd delivered a 71.1% ORR versus 70.5% for Sarclisa IV-Pd (RR 1.008; 95% CI 0.903\u20131.126), with a significantly shorter treatment time and fewer infusion-related reactions. Systemic administration reactions fell from 25% with IV to 1.5% with SC; injection site reactions occurred in 0.4% of OBI injections, nearly all grade 1.
\nWhy it matters: This resolves the FDA review that had been extended to a July 23 PDUFA \u2014 approval landed roughly two weeks early. The on-body injector is a genuine administration-paradigm shift in myeloma: it removes both the IV infusion chair-time burden and the physical strain of high-resistance manual SC injection on nursing staff, while preserving Sarclisa’s established efficacy. It directly pressures daratumumab SC (Darzalex Faspro, J&J) on convenience \u2014 the two anti-CD38 antibodies now compete on delivery experience as much as efficacy, and Sarclisa is the only anti-CD38 in myeloma offering both OBI and manual SC.
\nSignal Strength: \u26ab 4 \u2014 Major Milestone (first-in-class delivery approval; catalyst resolved from watchlist)<\/p>\n","protected":false},"excerpt":{"rendered":"
Company: Sanofi (EURONEXT: SAN; Nasdaq: SNY) Event Type: FDA approval \u2014 subcutaneous formulation, ahead of the July 23 PDUFA Modality: Anti-CD38 monoclonal antibody, subcutaneous \u2014 delivered via CirCLIQ on-body injector (Enable Injections enFuse platform) and manual SC Target: CD38 Indication: Multiple myeloma \u2014 all currently approved Sarclisa IV indications (NDMM transplant-ineligible; R\/R MM combinations) Summary: […]<\/p>\n","protected":false},"author":1,"featured_media":1970,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,11,3],"tags":[],"class_list":["post-1969","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-all-categories","category-clinical","category-therapeutic-indication"],"blocksy_meta":[],"_links":{"self":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts\/1969","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1969"}],"version-history":[{"count":1,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts\/1969\/revisions"}],"predecessor-version":[{"id":1971,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/posts\/1969\/revisions\/1971"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=\/wp\/v2\/media\/1970"}],"wp:attachment":[{"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1969"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1969"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.insilens.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1969"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}