Sanofi's Sarclisa Secures FDA Approval For First-Line Multiple Myeloma, Marking Its Third US Approval
The FDA approved Sanofi's Sarclisa (isatuximab) in combination with VRd as a first-line treatment for newly diagnosed multiple myeloma patients ineligible for stem cell transplants. Sarclisa is the first anti-CD38 therapy with VRd to significantly reduce disease progression or death by 40%.
Sanofi's Sarclisa Gets FDA Nod for Expanded Use in Multiple Myeloma
Sanofi SNY announced that the FDA has approved the label expansion for the use of its multiple myeloma (MM) drug, Sarclisa (isatuximab). With this nod, Sarclisa is now approved in combination with Velcade (bortezomib),
Sanofi breaks into first-line multiple myeloma with FDA approval for Sarclisa
Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. That changed Friday. | Since an initial FDA go-ahead in 2020,
Sanofi wins US approval for multiple myeloma drug in newly diagnosed patients
The U.S. Food and Drug Administration said on Friday it has approved the use of a drug combination along with Sanofi's Sarclisa infusion as a treatment for certain types of newly diagnosed multiple myeloma patients.
Sanofi’s Multiple Sclerosis Drug Slows Disease’s Progression
Sanofi’s experimental drug for a form of multiple sclerosis delayed the progression of disability by nearly a third, providing hope for patients for whom there’s currently no treatment.
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Sanofi's Sarclisa gets one up on rival Darzalex in myeloma
The FDA has approved Sarclisa (isatuximab) as a first-line therapy for blood cancer multiple myeloma as a combination regimen ...
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Sarclisa approved in the US as the first anti-CD38…
Approval based on positive results from the IMROZ phase 3 study demonstrating Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved progression-free ...
The Pharma Letter9h
Sanofi’s Sarclisa gains third FDA approval
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first line treatment option for adult patients ...
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IMS 2024 to Serve as Victory Lap for MRD “Success Story”
The 21st annual meeting of the International Myeloma Society takes place September 25-28, 2024, in Rio de Janiero, Brazil.
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FDA Approves Sarclisa In Newly Diagnosed Transplant-Ineligible Multiple Myeloma
The Food and Drug Administration has approved Sarclisa as a first-line treatment for patients with multiple myeloma who are ...
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Isatuximab Approved First-Line for Transplant-Ineligible MM
In addition to other MM indications, Isatuximab's anti-CD38 competitor on the US market, daratumumab (Darzalex — Johnson & Johnson), also carries a first-line indication for transplant-ineligible MM ...
Black Diamond Therapeutics' Lead Drug Candidate Shows Initial Anti-tumor Activity In Certain Type Of Lung Cancer Resistant To AstraZeneca's Drug
Black Diamond Therapeutics reports promising initial Phase 2 data for BDTX-1535 in relapsed EGFR-mutant NSCLC patients. With ...
Regulatory News | Today's Latest Stories | Reuters
Reuters.com is your online source for the latest news stories and current events, ensuring our readers up to date with any ...
Sanofi Says FDA Approves Sarclisa for Treatment of Blood Cancer Patients
Sanofi said the Food and Drug Administration has approved Sarclisa as a first line combined treatment option for adult patients with newly diagnosed multiple myeloma who aren't eligible for autologous ...