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.
Category: FDA Approvals
OPDIVO® (Nivolumab)
The FDA on August 19, 2021 approved OPDIVO® for the adjuvant treatment of patients with Urothelial Carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. OPDIVO® is a product of Bristol-Myers Squibb Co.
JEMPERLI® (Dostarlimab-gxly)
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.
WELIREG® (Belzutifan)
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.
LENVIMA® (Lenvatinib) plus KEYTRUDA® (Pembrolizumab)
The FDA on August 10, 2021 approved the combination of LENVIMA® plus KEYTRUDA® for first-line treatment of adult patients with advanced Renal Cell Carcinoma (RCC). LENVIMA® is a product of Eisai Co., Ltd. and KEYTRUDA® is a product of Merck & Co.
KEYTRUDA® (Pembrolizumab)
The FDA on July 26, 2021 approved KEYTRUDA® for high-risk, early-stage, Triple-Negative Breast Cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA® is a product of Merck & Co.
KEYTRUDA® (Pembrolizumab) in combination with LENVIMA® (Lenvatinib)
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.
REZUROCK® (Belumosudil)
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.
DARZALEX FASPRO® (Daratumumab and Hyaluronidase-fihj)
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.
PADCEV® (Enfortumab Vedotin-ejfv)
The FDA on July 9, 2021 approved PADCEV®, a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who
- 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.