Opdivo
BMS third quarter revenues increased 8 percent to $11.90 billion, with its growth portfolio now making up half of total revenues.
The agency is considering whether to limit the indications of Keytruda, Opdivo, and Tevimbra to PD-L1-positive patients amid testing uncertainties.
FDA Expert Panel to Consider Limiting Gastric, Esophageal Cancer Immunotherapies to PD-L1 Expressors
The ODAC will weigh risk-benefit analyses from the FDA and sponsors on Keytruda, Opdivo, and Tevimbra when given with chemo in all-comers and in PD-L1-positive subgroups.
Researchers at the ESMO Congress presented data showing better responses on dual-checkpoint blockade in the biomarker-defined subset relative to all-comers.
Sales of the CAR T-cell therapy continue to grow helped by BMS's expansion of its cell manufacturing facilities.