Lunsumio Approved for Relapsed or Refractory Follicular Lymphoma
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells.
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody that targets CD20 on the surface of B cells and CD3 on the surface of T cells.
The approval was based on data from the phase 3 SEQUOIA and ALPINE studies in patients with CLL/SLL.
As a noncovalent inhibitor of BTK, pirtobrutinib is able to reestablish BTK inhibition in patients previously treated with covalent BTK inhibitors.
The approval was based on data from the phase 1/2 ZUMA-3 trial which evaluated Tecartus in 71 adults with relapsed or refractory B-cell precursor ALL.
Lumoxiti was approved by the FDA in September 2018 for the treatment of adults with relapsed or refractory hairy cell leukemia.
Olutasidenib is a small-molecule inhibitor of mutated IDH1.
Epcoritamab is designed to bind to CD3 on T cells and CD20 on B cells, inducing T cell mediated killing of CD20+ cells.
The MWF dosing option was approved under the Real-Time Oncology Review program based on data from the intramuscular administration part of a phase 2/3 trial.
The approval was based on data from the open-label phase 3 AHOD1331 trial.
Following an initial extensive review, the Agency identified less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant.