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.
Category: FDA Approvals
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.
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.