Janssen and Legend Biotech are seeking U.S. approval for their investigational CAR T-cell therapy ciltacabtagene autoleucel — known as cilta-cel — to treat adults with relapsed or refractory (hard-to-treat) multiple myeloma. A rolling submission of the biologics license application (BLA) for cilta-cel has been started by Janssen…
The U.S. Food and Drug Administration (FDA) has approved a triple combination of Xpovio (selinexor) plus Velcade (bortezomib) and low-dose dexamethasone for the treatment of people with multiple myeloma who received at least one line of therapy. The approval, which comes three months ahead of deadline, was based…
A new initiative by GlaxoSmithKline (GSK) is seeking project proposals that will address key needs for people in the multiple myeloma community. Submissions for the Target the Future Think Tank Challenge are open until Feb. 11. Anyone in the community, including patients, caregivers, researchers, clinicians, and advocates, all…
PF-06863135, a bispecific antibody being developed by Pfizer as an injectable treatment, shows a manageable safety profile and promising response rates at high dose in heavily pre-treated patients with relapsed or refractory multiple myeloma, according to early data from an ongoing Phase 1/2 trial. “The very high response…
Ciltacabtagene autoleucel, an investigational CAR T-cell therapy for multiple myeloma, continues to lead to deep and durable responses in heavily treated patients with relapsed or refractory disease, new data from the CARTITUDE-1 clinical trial show. The findings were shared recently in the oral presentation, “Phase 1b/2 Study…
The Multiple Myeloma Research Foundation (MMRF) has joined forces with the Dana Farber Cancer Institute to develop new biomarkers and treatments for people with smoldering multiple myeloma (SMM) — a precursor condition to multiple myeloma. The collaboration will take advantage of MMRF’s data hub CureCloud and at-home genetic test program and Dana Farber’s…
Cevostamab (BFCR4350A), a bispecific antibody developed by Roche, induces durable and deep responses in heavily pre-treated patients with relapsed or refractory multiple myeloma, according to early data from a Phase 1 trial. Preliminary data from the trial, called GO39775 (NCT03275103), also showed cevostamab…
Antengene is asking health authorities in Singapore, Australia, and Hong Kong to approve Xpovio (selinexor) for the treatment of multiple myeloma, the company announced in a press release. Specifically, the new drug applications will cover myeloma patients who have received at least four therapies, and failed to…
The Dana-Farber Cancer Institute and Quest Diagnostics, the laboratory testing company, are conducting a study to measure the prevalence of COVID-19 among individuals with or at risk of developing multiple myeloma. The aim of the Immune Profiling with Antibody-based COVID-19 Testing study, or IMPACT, is…
The U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on a Phase 1 trial assessing Cellectis’ investigational CAR T-cell therapy, UCARTCS1A, for the treatment of relapsed or refractory multiple myeloma. In September, the FDA placed a hold on the MELANI-01 trial (…
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