New US approval sought for Darzalex Faspro quadruple therapy
Johnson & Johnson (J&J) is seeking U.S. Food and Drug Administration (FDA) approval for a quadruple treatment regimen based on Darzalex Faspro (daratumumab…
News
Carvykti lowering risk of death as second-line myeloma therapy: Trial
A single infusion of the cell therapy Carvykti (ciltacabtagene autoleucel) reduced the risk of death by 45% relative to standard treatment regimens for multiple…
FDA approves Sarclisa regimen as first-line treatment for myeloma
The U.S. Food and Drug Administration has approved Sanofi’s Sarclisa (isatuximab) in combination with standard-of-care treatment for adults with newly diagnosed multiple myeloma…
FDA grants Poseida’s CAR T-cell therapy RMAT status for RRMM
The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) status to P-BCMA-ALLO1, Poseida Therapeutics‘ experimental CAR T-cell therapy for…
Ready-to-use bortezomib formula Boruzu OK’d for multiple myeloma
The U.S. Food and Drug Administration (FDA) has approved Boruzu, a ready-to-use injectable formulation of bortezomib, for treating adults with multiple myeloma and mantle…
Blood Cancer Awareness Month is an opportunity to #kNOwMyeloma
Supporters are gearing up to learn, educate, and fundraise in observance of Blood Cancer Awareness Month, which is held each September to increase awareness…
FDA declines linvoseltamab decision for RRMM due to facility issue
The U.S. Food and Drug Administration (FDA) has rejected Regeneron Pharmaceuticals’ application for approval of linvoseltamab to treat adults with relapsed or refractory…
Phase 3 trial of CAR T-cell therapy anito-cel for RRMM opens
Kite Pharma has initiated iMMagine-3, a global Phase 3 clinical trial that’s set to test anitocabtagene autoleucel (anito-cel), an investigational CAR T-cell therapy, against…
First-line induction therapy with Sarclisa delays myeloma progression
Adding Sarclisa (isatuximab) to standard induction therapy for transplant-eligible people with newly diagnosed multiple myeloma extends the time patients live without their disease…
FDA adds Darzalex Faspro to combo therapy for newly diagnosed MM
The U.S. Food and Drug Administration (FDA) has approved a new quadruple regimen including Darzalex Faspro (daratumumab and hyaluronidase-fihj) as a first-line approach for adults…
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