Gilead Sciences
European Commission Approves Gilead's Trodelvy for Metastatic TNBC
The EC approved Gilead's Trop-2 directed antibody drug conjugate for advanced, pretreated TNBC patients based on the results of the Phase III ASCENT study.
Gilead Sciences Q3 CAR T-Cell Therapy Sales Increase 51 Percent
The firm's overall revenues increased 13 percent to $7.42 billion, driven in part by new autologous CAR T-cell therapy indications.
Agencies and drugmakers are struggling to generate consistent standards and regulatory criteria for evaluating autologous cell therapies.
CHMP Recommends Gilead's Trodelvy for Pretreated TNBC
The committee recommended that sacituzumab govitecan be approved in Europe for metastatic triple-negative breast cancer patients after two or more lines of treatment.
FDA Approves Gilead's Tecartus for Acute Lymphoblastic Leukemia
The agency approved the second indication for the autologous, CD19-directed CAR T-cell therapy based on the results of the Phase I/II ZUMA-3 trial.