Margarida Maia, PhD, science writer —

The U.S. Food and Drug Administration (FDA) has rejected Regeneron Pharmaceuticals’ application for approval of linvoseltamab to treat adults with relapsed or refractory multiple myeloma (RRMM), and at least three prior lines of therapy, due to an issue at a manufacturing site. In a complete response letter…

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 standard care in adults with relapsed or refractory multiple myeloma (RRMM). The announcement was made by Arcellx, Kite’s partner in the development of…

Adding Sarclisa (isatuximab) to standard induction therapy for transplant-eligible people with newly diagnosed multiple myeloma extends the time patients live without their disease progressing, regardless of the maintenance regimen they subsequently receive. That’s according to the latest data from the Phase 3 GMMG-HD7 clinical trial (NCT03617731), which…

A committee of the European Medicines Agency (EMA) has accepted for review GSK’s marketing authorization application for Blenrep (belantamab mafodotin) to be used as part of a combination treatment for people with relapsed or refractory multiple myeloma (RRMM). The Committee for Medicinal Products for Human Use (CHMP) will…

Through its Myeloma Investment Fund, the Multiple Myeloma Research Foundation (MMRF) has invested $1 million in novel CAR T-cell technology from Dynamic Cell Therapies (DCT) that aims to better treat multiple myeloma. Backed by this investment, DCT remains on track to move a new CAR T-cell…

A Phase 3 clinical trial evaluating the safety and efficacy of AbbVie’s experimental therapy ABBV-383 in adults with relapsed or refractory multiple myeloma (RRMM) has treated its first patient. Called CERVINO (NCT06158841), the study plans to enroll up to 380 patients, ages 18 and older, at…

A unanimous vote by a committee of the U.S. Food and Drug Administration (FDA) could lead to an early outcome measure — one known as minimal residual disease, or MRD negativity — being used for accelerated approval of treatments in clinical trials of…

Health Canada has granted conditional approval to Pfizer’s Elrexfio (elranatamab-bcmm), expanding the list of countries where the medication can be used for adults with multiple myeloma whose cancer has returned and who have not responded to previous treatment. The conditional approval, officially a Notice of Compliance, will require…

Bristol Myers Squibb has received a positive opinion from an arm of the European Medicines Agency (EMA) on the use of its CAR T-cell therapy Abecma (idecabtagene vicleucel) in earlier lines of treatment for relapsed and hard-to-treat multiple myeloma. Abecma already is approved in the European Union…

AstraZeneca is set to buy Gracell Biotechnologies in a deal worth up to $1.2 billion that would add GC012F — an experimental dual-targeting CAR T-cell therapy being developed for multiple myeloma and other hematologic or blood-borne cancers — to the buyer’s pipeline. CAR T-cell therapy works…