Biosimilar Riabni Gets FDA Approval
The biosimilar has been approved for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, and Microscopic Polyangiitis.
Leukemias/lymphomas/ And Other Hematologic Cancers
Loncastuximab Tesirine Gets Priority Review for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Loncastuximab tesirine is an antibody drug conjugate composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine dimer cytotoxin.
FDA Grants Full Approval to Venclexta for Acute Myeloid Leukemia
The full approval was based on efficacy and safety data from the phase 3 VIALE-A (M15-656) and VIALE-C (M16-043) studies.
Keytruda Approval Expands Classical Hodgkin Lymphoma Indication
The expanded approval was based on data from the randomized, open-label, phase 3 KEYNOTE-204 trial.
Oral AML Therapy Onureg Gets FDA Approval
The approval was based on data from the multicenter, randomized, double-blind, placebo-controlled, phase 3 QUAZAR study.
Daratumumab Combo Approved for Relapsed/Refractory Multiple Myeloma
The approval was based on data from the phase 3 CANDOR study and the phase 1b EQUULEUS trial.
Blenrep Approved for Relapsed/Refractory Multiple Myeloma
Blenrep is a humanized, afucosylated, IgG1 anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent, monomethyl auristatin F.
Monjuvi Approved for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Tafasitamab-cxix is a humanized Fc-modified monoclonal antibody that targets CD19 antigen on the surface of pre-B and mature B lymphocytes and on several B-cell malignancies, including DLBCL.
First CAR T-Cell Therapy Approved for Mantle Cell Lymphoma
The FDA has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel; Kite Pharma) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
FDA Panel Votes on Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma
The FDA Oncologic Drugs Advisory Committee voted in favor (12-0) of the approval of belantamab mafodotin (GSK2857916; GlaxoSmithKline) for patients with relapsed or refractory multiple myeloma.
