The FDA on October 28, 2015 approved YERVOY® injection for the additional indication of adjuvant treatment of patients with Cutaneous Melanoma, with pathologic involvement of regional lymph nodes of more than 1 mm, who have undergone complete resection, including total lymphadenectomy. YERVOY® is a product of Bristol-Myers Squibb Company.
Category: FDA Approvals
YONDELIS® (Trabectedin)
The FDA on October 23, 2015 approved YONDELIS®) for the treatment of patients with unresectable or metastatic Liposarcoma or Leiomyosarcoma who have received a prior Anthracycline-containing regimen. YONDELIS® injection is a product of Janssen Biotech, Inc.
ONIVYDE® (Irinotecan liposome injection)
The FDA on October 22, 2015 approved ONIVYDE® injection, administered in combination with Fluorouracil (5-FU) and Leucovorin, for the treatment of patients with metastatic Adenocarcinoma of the Pancreas, whose disease has progressed following Gemcitabine-based therapy. ONIVYDE® injection is a product of Merrimack Pharmaceuticals, Inc
PRAXBIND® (Idarucizumab)
The FDA on October 16, 2015 granted accelerated approval to PRAXBIND® for the treatment of patients treated with PRADAXA® (Dabigatran), when reversal of the anticoagulant effects of PRADAXA® is needed for emergency surgery/urgent procedures, or in life-threatening or uncontrolled bleeding. PRAXBIND® injection is a product of Boehringer Ingelheim Pharmaceuticals, Inc.
OPDIVO® (Nivolumab)
The FDA on October 9, 2015 approved OPDIVO® for the treatment of patients with metastatic Non Small Cell Lung Cancer (NSCLC), with progression on or after Platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations, prior to receiving OPDIVO®. OPDIVO® Injection is a product of Bristol-Myers Squibb Company.
KEYTRUDA® (Pembrolizumab)
The FDA on October 2, 2015 granted accelerated approval to KEYTRUDA® for the treatment of patients with metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors express Programmed Death Ligand 1 (PD-L1) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. KEYTRUDA® Injection is a product of Merck Sharp and Dohme Corporation.
OPDIVO® (Nivolumab)
The FDA on September 30, 2015 granted accelerated approval to OPDIVO® in combination with YERVOY® (Ipilimumab), for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma. OPDIVO® Injection is a product of Bristol-Myers Squibb Company.
LONSURF® (Trifluridine/Tipiracil)
The FDA on September 22, 2015 approved LONSURF® for the treatment of patients with metastatic colorectal cancer, who have been previously treated with Fluoropyrimidine, Oxaliplatin and Irinotecan-based chemotherapy, an anti-VEGF biologic product, and an anti-EGFR monoclonal antibody, if RAS wild-type. LONSURF® is a product of Taiho Oncology, Inc.
PROMACTA® (Eltrombopag)
The FDA on August 24, 2015 approved PROMACTA® for the treatment of thrombocytopenia in pediatric patients 1 year and older with chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP), who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA® oral suspension is a product of Novartis Pharmaceuticals Corporation.
ADCETRIS® (Brentuximab vedotin)
The FDA on August 17, 2015 approved ADCETRIS® for the post-autologous Hematopoietic Stem Cell Transplantation (auto-HSCT) consolidation treatment of patients with classical Hodgkin Lymphoma (HL) at high risk of relapse or progression. ADCETRIS® is a product of Seattle Genetics, Inc.