Cabometyx Approved for Radioactive Iodine-Refractory Differentiated Thyroid Cancer
The approval was based on data from the phase 3 COSMIC-311 study.
Pancreatic/Thyroid/Other Endocrine Cancers
Jemperli Gets Accelerated Approval for dMMR Recurrent or Advanced Solid Tumors
The accelerated approval was based on data from the phase 1 GARNET trial.
FDA to Review Cabozantinib for Differentiated Thyroid Cancer
The sNDA is supported by data from the phase 3 COSMIC-311 study.
ATA Issues Guidelines for Managing Anaplastic Thyroid Cancer
Evidence-based guidelines address diagnosis, evaluation, and treatment, including early multidisciplinary care team involvement
FDA-Approved VEGFR Tyrosine Kinase Inhibitors Ranked by Cardiotoxic Potential
Lenvatinib was associated with the most significant probability of producing all grades of cardiovascular injury and hypertension.
Cabozantinib Gets Breakthrough Tx Status for Differentiated Thyroid Cancer
The designation is supported by data from the randomized, double-blind, placebo-controlled phase 3 COSMIC-311 study.
Gavreto Gets Accelerated Approval for RET-Altered Thyroid Cancers
The approval was based on data from the phase 1/2 ARROW trial which evaluated the efficacy and safety of Gavreto in patients with RET-mutant MTC.
FDA Approves Radioactive Diagnostic Agent Detectnet
Detectnet (copper Cu 64 dotatate) is indicated for use with PET for localization of somatostatin receptor positive neuroendocrine tumors.
Zenocutuzumab Gets Orphan Drug Designation for Pancreatic Cancer
Zenocutuzumab is a first-in-class bispecific antibody that binds to HER2 and HER3 receptors, thereby blocking the interaction of HER3 with its ligand neuregulin 1 (NRG1) or NRG1-fusion proteins.
FDA Approves Keytruda for Tumor Mutational Burden-High Cancer
The accelerated approval was based on data from a prospectively-planned retrospective analysis of 10 cohorts of patients with various previously treated unresectable or metastatic solid tumors with TMB-H who were enrolled in the open-label phase 2 KEYNOTE-158 trial.
