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.
Author: RR
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.
VENCLEXTA® (Venetoclax)
The FDA on November 21, 2018 granted accelerated approval to VENCLEXTA® in combination with Azacitidine or Decitabine or low-dose Cytarabine for the treatment of newly-diagnosed Acute Myeloid Leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. VENCLEXTA® is a product of AbbVie Inc. and Genentech Inc.
DAURISMO® (Glasdegib)
The FDA on November 21, 2018 approved DAURISMO® in combination with Low-Dose Cytarabine (LDAC), for newly-diagnosed Acute Myeloid Leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy. DAURISMO® is a product of Pfizer Labs.
GAMIFANT® (Emapalumab)
The FDA on November 20, 2018 approved GAMIFANT®, a monoclonal antibody that binds and neutralizes Interferon Gamma, for adult and pediatric (newborn and older) patients with primary Hemophagocytic Lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. GAMIFANT® is a product of Novimmune SA.
ADCETRIS® (Brentuximab vedotin)
The FDA on November 16, 2018 approved ADCETRIS® in combination with chemotherapy for previously untreated systemic Anaplastic Large Cell Lymphoma or other CD30-expressing Peripheral T-Cell Lymphomas. ADCETRIS® is a product of Seattle Genetics Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on November 9, 2018 granted accelerated approval to KEYTRUDA® for patients with Hepatocellular Carcinoma (HCC) who have been previously treated with Sorafenib. KEYTRUDA® is a product of Merck & Co. Inc.
LORBRENA® (Lorlatinib)
The FDA on November 2, 2018 granted accelerated approval to LORBRENA®, for patients with Anaplastic Lymphoma Kinase (ALK)-positive metastatic Non-Small Cell Lung Cancer (NSCLC) whose disease has progressed on Crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on Alectinib or Ceritinib as the first ALK inhibitor therapy for metastatic disease. LORBRENA® is a product of Pfizer, Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on October 16, 2018 approved KEYTRUDA® in combination with Carboplatin and either Paclitaxel or nab-Paclitaxel, as first-line treatment of metastatic squamous Non-Small Cell Lung Cancer (NSCLC). KEYTRUDA® is a product of Merck & Co. Inc.