The FDA on August 25, 2021 approved TIBSOVO® (Ivosidenib) for adult patients with previously treated, locally advanced or metastatic Cholangiocarcinoma with an Isocitrate DeHydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. TIBSOVO® is a product of Servier Pharmaceuticals, LLC.
The FDA on August 18, 2021 granted accelerated approval to JEMPERLI® for adult patients with MisMatch Repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. JEMPERLI® is a product of GlaxoSmithKline LLC.
The FDA on August 13, 2021 approved WELIREG®, a Hypoxia-Inducible Factor inhibitor for adult patients with Von Hippel-Lindau (VHL) disease who require therapy for associated Renal Cell Carcinoma (RCC), Central Nervous System (CNS) Hemangioblastomas, or Pancreatic NeuroEndocrine Tumors (pNET), not requiring immediate surgery. WELIREG® is a product of Merck & Co.
The FDA on July 21, 2021 approved KEYTRUDA® in combination with LENVIMA® for patients with advanced Endometrial carcinoma that is not MicroSatellite Instability-High (MSI-H) or MisMatch Repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting, and are not candidates for curative surgery or radiation. KEYTRUDA® is a product of Merck & Co. and LENVIMA® is a product of Eisai Co., Ltd.
The FDA on July 16, 2021 approved REZUROCK®, a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic Graft-Versus-Host Disease (chronic GVHD), after failure of at least two prior lines of systemic therapy. REZUROCK® is a product of Kadmon Pharmaceuticals, LLC.
The FDA on July 9, 2021 approved DARZALEX FASPRO® in combination with Pomalidomide and Dexamethasone for adult patients with Multiple Myeloma, who have received at least one prior line of therapy including Lenalidomide and a Proteasome Inhibitor. DARZALEX FASPRO® is a product of Janssen Biotech, Inc.
- have previously received a Programmed Death receptor-1 (PD-1) or Programmed Death-Ligand (PD-L1) inhibitor and Platinum-containing chemotherapy, or
- are ineligible for Cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
PADCEV® is a product of Astellas Pharma US, Inc.