FDA puts CART-ddBCMA Phase 2 trial on hold after patient’s death
The U.S. Food and Drug Administration (FDA) has placed a hold on clinical testing of CART-ddBCMA, a cell therapy that Arcellx and Kite…
Myeloma
Phase 1b trial of STAR-LLD combo for myeloma approved by FDA
The U.S. Food and Drug Administration (FDA) has cleared the launch of a Phase 1b trial to test STAR-LLD, Starton Therapeutics’ experimental continuous delivery…
FDA asked to extend Carvykti to myeloma patients after first relapse
Janssen is asking the U.S. Food and Drug Administration (FDA) to expand approval its cell therapy Carvykti (ciltacabtagene autoleucel) to allow for earlier…
FDA Clears Way for Clinical Trial of HDP-101
Heidelberg Pharma has been cleared in the U.S. to begin a clinical trial testing its investigational therapy HDP-101 for the treatment of…
Under-the-skin Velcade Found to Work Better in Farydak Triple Combo
Using an under-the-skin formulation of Velcade (bortezomib), in combination with Farydak (panobinostat) and oral dexamethasone, leads to a better safety profile in people…
Phase 3 Trial of ATG-010 (Xpovio) for Advanced Myeloma Opens in China
China’s regulatory agency has approved the start of a Phase 3 clinical trial testing ATG-010 (selinexor), in combination with Velcade (bortezomib) and dexamethasone, in …
EMA Plans Speedy Review of Cilta-cel, CAR T-cell Therapy for Advanced Myeloma
An accelerated review will be given an application for European Union approval of ciltacabtagene autoleucel (cilta-cel), a potential CAR T-cell therapy for heavily pre-treated multiple myeloma patients,…
EU Committee Supports Nexpovio for Heavily Treated Myeloma Patients
A combination of Nexpovio (selinexor) and the corticosteroid dexamethasone has been recommended for conditional approval in the European Union to treat adults with relapsed…
Dosing Begins in Phase 1 Trial of CERC-007
Cerecor has dosed the first patient in a Phase 1b clinical trial evaluating  CERC-007 as a potential treatment for relapsed or refractory multiple…
Jakafi Plus Steroid Continuing to Treat Multiple Myeloma in Phase 1 Trial
Combining the corticosteroid methylprednisolone and Jakafi (ruxolitinib), an approved oral therapy for bone marrow disorders, is showing promising effectiveness in heavily pre-treated multiple myeloma…
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