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.
Category: FDA Approvals
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.
TALZENNA® (Talazoparib)
The FDA on October 16, 2018 approved TALZENNA®, a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2 negative, locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for TALZENNA®. TALZENNA® is a product of Pfizer Inc.
HEMLIBRA® (Emicizumab-kxwh)
The FDA on October 4, 2018 approved HEMLIBRA® injection for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (ages newborn and older) with Hemophilia A (congenital Factor VIII deficiency) with or without Factor VIII (FVIII) inhibitors. HEMLIBRA® is a product of Genentech, Inc.
LIBTAYO® (Cemiplimab-rwlc)
The FDA on September 28, 2018 approved LIBTAYO® for patients with metastatic Cutaneous Squamous Cell Carcinoma (CSCC) or locally advanced CSCC, who are not candidates for curative surgery or curative radiation. LIBTAYO® is a product of Regeneron Pharmaceuticals Inc.
VIZIMPRO® (Dacomitinib)
The FDA on September 27, 2018 approved VIZIMPRO® for the first-line treatment of patients with metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, as detected by an FDA-approved test. VIZIMPRO® is aproduct of Pfizer Pharmaceutical Company.
COPIKTRA® (Duvelisib)
The FDA on September 24, 2018 granted regular approval to COPIKTRA® for adult patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Llymphoma (SLL) after at least two prior therapies. In addition, COPIKTRA® received accelerated approval for adult patients with Relapsed or Refractory Follicular Lymphoma (FL) after at least two prior systemic therapies. COPIKTRA® is a product of Verastem, Inc.