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.
Category: FDA Approvals
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.
KYPROLIS® (Carfilzomib)
The FDA on July 24, 2015 approved KYPROLIS® in combination with REVLIMID® (Lenalidomide) and Dexamethasone for the treatment of patients with relapsed multiple myeloma, who had received one to three prior lines of therapy. KYPROLIS® is a product of Onyx Pharmaceuticals, Inc., an Amgen subsidiary.
ODOMZO® (Sonidegib)
The FDA on July 24, 2015 approved ODOMZO® for the treatment of patients with locally advanced Basal Cell Carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. ODOMZO® capsules are a product of Novartis Pharmaceuticals Corporation
IRESSA® (Gefitinib)
The FDA on July 13, 2015 approved IRESSA® for the treatment of patients with metastatic Non Small Cell Lung Cancer (NSCLC), whose tumors have Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA approved test. IRESSA® was approved concurrently with a labeling expansion of the therascreen EGFR RGQ PCR Kit, a companion diagnostic test, for patient selection. IRESSA® tablets are a product of AstraZeneca Pharmaceuticals LP.