FDA

Legend Biotech has a target action date of February 28 for the company’s BLA for ciltacabtagene autoleucel (cilta-cel) for adults with relapsed and/or refractory multiple myeloma. The BLA was submitted by Legend’s collaboration partner, Janssen Biotech Inc., a Johnson & Johnson company.

The U.S. Food and Drug Administration approved Immunocore’s Kimmtrak (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM). 

Immunocore’s Phase III IMCgp100-202 trial of tebentafusp compared to investigator’s choice for metastatic uveal melanoma (mUM) met the pre-defined boundaries for statistical significance of the primary endpoint of overall survival in its first pre-planned interim analysis.