Following a months-long safety review, the regulator said it is now requiring black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.
Tag Archive for: CAR-T therapy
The FDA approved Bristol Myers Squibb’s Breyanzi for chronic lymphocytic leukemia and small lymphocytic leukemia prior to Friday’s adcomm for the company’s other CAR-T therapy, Abecma.
Staff reviewers said that the pattern of early deaths observed in patients treated with both the therapies in their respective trials raised uncertainty about the treatments’ overall survival benefit in patients.
The European Medicines Agency has recommended expanding Johnson & Johnson and Legend Biotech’s CAR-T therapy Carvytki (ciltacabtagene autoleucel) for use as an earlier treatment in patients with relapsed or refractory multiple myeloma, Legend announced on Friday.
After treatment with a CD19 CAR-T therapy, patients with systemic lupus erythematosus, idiopathic inflammatory myositis or systemic sclerosis achieved long-lasting remission, according to results published in the NEJM.
The FDA’s Peter Marks and Nicole Verdun in the NEJM Wednesday disclosed that more than 27,000 CAR-T doses have been administered in the U.S. as of the end of 2023, of which there are 22 cases of T-cell cancers.
Despite a new safety warning from the U.S. Food and Drug Administration, J&J still expects its cancer treatment to hit peak sales.
The investigational allogeneic CAR-T therapy P-BCMA-ALLO1 appears to be more effective following strong immunosuppressive preconditioning.
Biotech Beam Therapeutics has dosed the first patient in a Phase I/II study of its base-edited CAR-T therapy in relapsed or refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma.
The partnership with Chinese biotech Cellular Biomedicine Group will cost J&J $245 million upfront and give it access to two differentiated CAR-T therapies for diffuse large B-cell lymphoma.
