The FDA on December 21, 2018 approved ULTOMIRIS® for adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). ULTOMIRIS® is a product of Alexion Pharmaceuticals, Inc.
Category: FDA Approvals
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.
LYNPARZA® (Olaparib)
The FDA on December 19, 2018 approved LYNPARZA® for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in Complete or Partial Response to first-line platinum-based chemotherapy. LYNPARZA® is a product of AstraZeneca Pharmaceuticals LP.
KEYTRUDA® (Pembrolizumab)
The FDA on December 19, 2018 granted accelerated approval to KEYTRUDA® for adult and pediatric patients with recurrent locally advanced or metastatic Merkel Cell Carcinoma (MCC). KEYTRUDA® is a product of Merck & Co. Inc.
HERZUMA® (Trastuzumab-pkrb)
The FDA on December 14, 2018 approved HERZUMA® as a biosimilar to HERCEPTIN® (Trastuzumab) for patients with HER2-overexpressing breast cancer. HERZUMA® is a product of Celltrion Inc.
NPLATE® (Romiplostim)
The FDA on December 14, 2018 approved NPLATE® for pediatric patients 1 year of age and older with Immune Thrombocytopenia (ITP) for at least 6 months, who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. NPLATE® is a product of Amgen Inc.
TECENTRIQ® (Atezolizumab)
The FDA on December 6, 2018 approved TECENTRIQ® in combination with AVASTIN® (Bevacizumab), TAXOL® (Paclitaxel), and Carboplatin for the first-line treatment of patients with metastatic non-squamous, Non-Small Cell Lung Cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations. TECENTRIQ® is a product of Genentech, Inc.
XOSPATA® (Gilteritinib)
The FDA on November 28, 2018 approved XOSPATA® for treatment of adult patients who have relapsed or refractory Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. XOSPATA® is a product of Astellas Pharma US Inc.
TRUXIMA® (Rituximab-abbs)
The FDA on November 28, 2018 approved TRUXIMA® as the first biosimilar to RITUXAN® (Rituximab) for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL), to be used as a single agent or in combination with chemotherapy. TRUXIMA® is a product of Celltrion Inc.
VITRAKVI® (Larotrectinib)
The FDA on November 26, 2018 granted accelerated approval to VITRAKVI® for adult and pediatric patients with solid tumors that have a Neurotrophic Receptor Tyrosine Kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment. VITRAKVI® is a product of Loxo Oncology Inc. and Bayer.