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.
Lymphoma
Kymriah Gets Accelerated Approval for Relapsed/Refractory Follicular Lymphoma
The accelerated approval for Kymriah was based on data from the phase 2 ELARA trial.
Yescarta Approved for Second-Line Treatment of Large B-Cell Lymphoma
The approval was based on data from the phase 3 ZUMA-7 trial.
Yescarta Labeling Updated to Include Prophylactic Corticosteroid Use
The updated labeling is based on results from a safety management cohort from the ZUMA-1 study.
Incyte Withdraws Parsaclisib NDA for Follicular, Marginal Zone, and Mantle Cell Lymphomas
Parsaclisib is an investigational, highly selective, oral inhibitor of phosphatidylinositol 3-kinase delta.
New Drugs Approved in 2021
Visit our New Drug Products page to stay up-to-date on the latest drug approvals.
CAR-T Therapy May Improve Outcomes in Second-Line Relapsed/Refractory LBCL
Researchers sought to determine whether lisocabtagene maraleucel would improve outcomes compared with standard of care in second-line therapy in patients with LBCL.
Zanubrutinib Improves PFS, But May Not Improve OS, in Patients With Treatment-Naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Researchers sought to determine whether zanubrutinib would improve survival in patients with treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma.
Copiktra Indication for Relapsed/Refractory Follicular Lymphoma Withdrawn
The Company will be working with the FDA in the coming weeks to complete the label revision process.
Parsaclisib Under Review for Follicular, Marginal Zone, and Mantle Cell Lymphomas
The application is supported by data from several phase 2 studies.
