The FDA on March 8, 2019 granted accelerated approval to TECENTRIQ® in combination with Paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic Triple Negative Breast Cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering 1% or more of the tumor area), as determined by an FDA-approved test. The FDA also approved the VENTANA PD-L1 (SP142) Assay as a companion diagnostic device for selecting TNBC patients for TECENTRIQ®. TECENTRIQ® is a product of Genentech Inc.
Category: FDA Approvals
HERCEPTIN HYLECTA® (Trastuzumab and Hyaluronidase-oysk)
The FDA on February 28, 2019 approved HERCEPTIN HYLECTA®, a combination of HERCEPTIN® (Trastuzumab), a HER2/neu receptor antagonist, and Hyaluronidase, an endoglycosidase, for the treatment of HER2 overexpressing breast cancer. HERCEPTIN HYLECTA® is a product of Genentech Inc.
LONSURF® (Trifluridine/ Tipiracil)
The FDA on February 22, 2019 approved LONSURF® tablets, a fixed combination of Trifluridine, a nucleoside metabolic inhibitor, and Tipiracil, a thymidine phosphorylase inhibitor, for adult patients with metastatic Gastric or GastroEsophageal Junction (GEJ) adenocarcinoma, previously treated with at least two prior lines of chemotherapy that included a Fluoropyrimidine, a Platinum, either a Taxane or Irinotecan, and if appropriate, HER2/neu-targeted therapy. LONSURF® is a product of Taiho Pharmaceutical Co., Ltd.
KEYTRUDA® (Pembrolizumab)
The FDA on February 15, 2019 approved KEYTRUDA® for the adjuvant treatment of patients with Melanoma with involvement of lymph node(s) following complete resection. KEYTRUDA® is a product of Merck & Co., Inc.
CABLIVI® (Caplacizumab-yhdp)
The FDA on February 6, 2019 approved CABLIVI® for adult patients with acquired Thrombotic Thrombocytopenic Purpura (aTTP), in combination with Plasma Exchange and immunosuppressive therapy. CABLIVI® is a product of Ablynx NV.
ONTRUZANT® (Trastuzumab-dttb)
The FDA on January 18, 2019 granted approval to ONTRUZANT®, a Trastuzumab (HERCEPTIN®) biosimilar, for the treatment of patients with HER2-overexpressing Breast cancer or metastatic Gastric or GastroEsophageal Junction adenocarcinoma. The newly approved biosimilar will also eventually compete with 2 prior FDA approved biosimilars, OGIVRI® (Trastuzumab-dkst) and HERZUMA® (Trastuzumab-pkrb). ONTRUZANT® is a product of Samsung Bioepis and will be marketed by Merck&Co.
CABOMETYX® (Cabozantinib)
The FDA on January 14, 2019 approved CABOMETYX® for patients with HepatoCellular Carcinoma (HCC) who have been previously treated with NEXAVAR® (Sorafenib). CABOMETYX® is a product of Exelixis, Inc.
ELZONRIS® (Tagraxofusp-erzs)
The FDA on December 21, 2018 approved ELZONRIS®, a CD123-directed cytotoxin, for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS® is a product of Stemline Therapeutics.
ULTOMIRIS® (Ravulizumab-cwvz)
The FDA on December 21, 2018 approved ULTOMIRIS® for adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). ULTOMIRIS® is a product of Alexion Pharmaceuticals, Inc.
ASPARLAS® (Calaspargase pegol-mknl)
The FDA on December 20, 2018 approved ASPARLAS®, an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for Acute Lymphoblastic Leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years. This new product provides for a longer interval between doses compared to other available pegaspargase products. ASPARLAS® is a product of Servier Pharmaceuticals LLC.