The European Medicines Agency has validated a Marketing Authorization Application for the CD19-directed CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and grade 3B follicular lymphoma following at least 2 prior therapies.
The FDA has issued a clinical hold on the phase 1 MELANI-01 trial evaluating the CAR T-cell product UCARTCS1A in the treatment of patient with relapsed/refractory multiple myeloma.
Treatment with the CAR T-cell product lisocabtagene maraleucel led to high response rates, with durable complete responses, in transplant-ineligible patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma who had poor prognostic features.
The Data and Safety Monitoring Board has advised that the phase 3 DUBLIN-3 trial of the antineoplastic agent plinabulin in patients with advanced or metastatic non–small cell lung cancer who have progressed on standard-of-care therapy can continue without any modifications.
Peter Voorhees, MD, provides an overview of the many developments made with CAR T-cell therapy in multiple myeloma, as well as the exciting research being done with bispecific antibodies
Jean L. Koff, MD, MS, highlights exciting advances made in follicular lymphoma and the promise of CAR T-cell therapies in other lymphoma subtypes.
The emergence of monoclonal antibodies, immunomodulatory agents, immunotoxins, bispecific T-cell engagers, and CAR T-cell therapies will redefine multiple myeloma treatment. However, these new approaches, by themselves, are not enough to achieve cure; they must be used in combination.
Omar Nadeem, MD, highlights exciting approaches that have emerged in relapsed/refractory myeloma, such as CAR T-cell therapy, and shares unanswered questions that future research should address.
The Centers for Medicare & Medicaid Services has proposed to cover chimeric antigen receptor T-cell therapies approved by the FDA, under “Coverage with Evidence Development."
An ongoing randomized phase III study will compare the safety and efficacy of atezolizumab with placebo as adjuvant therapy after definitive local therapy in patients with high-risk, locally advanced squamous cell carcinoma of the head and neck.
The FDA has granted a fast track designation to FCX-013, a gene therapy for the treatment of patients with moderate to severe localized scleroderma.
The FDA has granted a priority review for an anti-PD-1 therapy for the treatment of adults and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.
The FDA grants an orphan drug designation to a novel gene therapy candidate for the treatment of patients with hereditary angioedema.
The FDA has granted a fast track designation to gene therapy product candidate AAV-CNGB3 for the treatment of achromatopsia caused by mutations in the CNGB3 gene.
New data demonstrates clinical benefit in hemophilia B patients with pre-existing anti-AAV5 neutralizing antibodies.
