Sanofi wins US approval for multiple myeloma drug in newly …
WEB2 days ago · Sept 20 - The U.S. Food and Drug Administration said on Friday it has approved the use of a drug combination along with Sanofi's (SASY.PA) Sarclisa infusion as a treatment for certain types of ...
Press Release: Sarclisa approved in the US as the first anti ... - Sanofi
WEB2 days ago · Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. 1 Kazandjian. Multiple myeloma epidemiology and survival: A unique malignancy.
Press Room - Sanofi US News
WEB3 days ago · PARIS, September 20, 2024. The US Food and Drug Administration (FDA) has approved SARCLISA (isatuximab-irfc) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT).
Sanofi moves on J&J in first-line myeloma with FDA nod
WEB3 days ago · ASCO: With first-in-class win, Sanofi's Sarclisa looks to step out of J&J's multiple myeloma shadow. Challenging Darzalex won’t be easy. Worldwide sales of the J&J med jumped 22% and reached $9. ...
FDA approves isatuximab-irfc with bortezomib, lenalidomide, and ...
WEB3 days ago · On September 20, 2024, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) with bortezomib, lenalidomide, and dexamethasone for adults with newly ...
Press Release: Sarclisa approved in the US as the first anti
WEB2 days ago · Advancing Sarclisa in multiple myeloma. Sanofi continues to advance Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies across ...
Press Room - Sanofi US News
WEBAug 8, 2024 · GMMG-HD7 is one of six phase 3 studies to report positive results for Sarclisa in multiple myeloma (MM), which includes four positive readouts of a Sarclisa-based quadruplet in the frontline setting. Results reinforce the potential of Sarclisa as a backbone therapy when added to the current standard-of-care in …
Press Room - Sanofi US News
WEBMay 27, 2024 · Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma (MM) cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activities.
Press Release: Sarclisa accepted for FDA priority review for ... - Sanofi
WEBMay 27, 2005 · If approved, Sarclisa would be the first anti-CD38 therapy in combination with standard-of-care treatment for patients with newly diagnosed transplant-ineligible multiple myeloma. Pivotal IMROZ phase 3 study results to be featured during oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Paris, May 27 ...
FDA Approves Isatuximab/VRd in Newly Diagnosed Multiple Myeloma
WEB3 days ago · Transplant-ineligible patients 80 years or younger with NDMM in the prospective, open-label study across 102 sites and 21 countries were randomly assigned 3:2 to receive isa-VRd or VRd alone. Patients received 10 mg/kg of isatuximab intravenously once weekly for 5 weeks in the first 42-day cycle, followed by every other week up to cycle 4 ...
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