Breyanzi Approved as Second-Line Treatment for Large B-Cell Lymphoma
The expanded approval was based on data from the phase 3 TRANSFORM and phase 2 PILOT studies.
The expanded approval was based on data from the phase 3 TRANSFORM and phase 2 PILOT studies.
The accelerated approval for Kymriah was based on data from the phase 2 ELARA trial.
The approval was based on data from the phase 3 ZUMA-7 trial.
The updated labeling is based on results from a safety management cohort from the ZUMA-1 study.
Parsaclisib is an investigational, highly selective, oral inhibitor of phosphatidylinositol 3-kinase delta.
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Researchers sought to determine whether lisocabtagene maraleucel would improve outcomes compared with standard of care in second-line therapy in patients with LBCL.
Researchers sought to determine whether zanubrutinib would improve survival in patients with treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma.
The Company will be working with the FDA in the coming weeks to complete the label revision process.
The application is supported by data from several phase 2 studies.