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.
Pancreatic/Thyroid/Other Endocrine Cancers
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.
New Drug Product: Retevmo
This slideshow shows drug information for Retevmo. Click here for the complete Retevmo monograph.
Retevmo Gets Accelerated Approval for RET-Driven Lung, Thyroid Cancers
The FDA has granted accelerated approval to Retevmo™ (selpercatinib; Lilly).
Lynparza Gains Pancreatic Cancer Indication
AstraZeneca and Merck announced that the Food and Drug Administration (FDA) has approved Lynparza (olaparib) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. The FDA’s Oncologic Drugs Advisory Committee…
Development of Pancreatic Cancer Tx to Be Discontinued Following Disappointing Trial Results
Halozyme Therapeutics announced that the phase 3 HALO-301 study of PEGPH20 as a first-line therapy for treatment of patients with metastatic pancreatic cancer has failed to meet the primary end point of overall survival.
New Drug Product: Rozlytrek
This slideshow shows drug information for Rozlytrek. Click here for the complete Rozlytrek monograph.
Antifibrotic Therapy for Chronic Pancreatitis Gets Orphan Drug Designation
The Food and Drug Administration (FDA) has granted Orphan Drug designation to TLY012 (Theraly Fibrosis) for the treatment of chronic pancreatitis.
