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 adults with relapsed or refractory multiple myeloma (RRMM). The designation is specifically indicated for treating patients who have relapsed or failed to respond after…
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 cell lymphoma. While a bortezomib formulation sold as Velcade has been used for years for these forms of blood cancer, Boruzu is expected to…
Supporters are gearing up to learn, educate, and fundraise in observance of Blood Cancer Awareness Month, which is held each September to increase awareness of all types of blood cancer, including myeloma, lymphoma, and leukemia. The International Myeloma Foundation (IMF) will revive its #kNOwMyeloma educational campaign, which…
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…
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 with newly diagnosed multiple myeloma and eligible for a stem cell transplant. Johnson & Johnson’s Darzalex Faspro now can be used in…
A blood test measuring numbers of lymphocytes, a type of immune cell, may predict how well people with relapsed multiple myeloma will respond to a CAR T-cell therapy targeting the BCMA protein, according to a multicenter study in New York. The test measures absolute lymphocyte count, or ALC, and…
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…
Get regular updates to your inbox.