Weekly Drug News Round-Up: August 30, 2017
Kymriah from Novartis Approved as First U.S. CAR-T Cell Therapy
Refractory or relapsed ALL occurs in roughly 15-20 percent of patients Read More...
History was made today, as the U.S. Food and Drug Administration FDA approved the first U.S. cell-based gene therapy known collectively as chimeric antigen receptor (CAR) T-cell therapy. Kymriah (tisagenlecleucel), from Novartis, was approved for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Kymriah is a genetically-modified T-cell immunotherapy customized for each patient using their own T-cells, a type of white blood. In one study of 63 pediatric and young adult patients with relapsed or refractory B-cell precursor ALL, the overall remission rate within three months of treatment was 83 percent. Kymriah contains a boxed warning for cytokine release syndrome (CRS) and neurotoxicity.
To learn more, visit the Drugs.com slideshow: CAR T-Cell Therapy: A Healthcare Professional's Guide - The Top 10 Questions Answered
Cyltezo: Boehringer Ingelheim Gets Approval on Their First Biosimilar
This is the 6th FDA-approved biosimilar; the second for Abbvie’s Humira Read More...
Cyltezo (adalimumab-adbm) is an anti-TNF-α monoclonal antibody biosimilar to Humira, approved in a pre-filled syringe for the treatment of various inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. It can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs. (DMARDs). No FDA Advisory committee convened for discussion of Cyltezo; it was approved based on a comprehensive data package comprised of analytical, pharmacological, non-clinical and clinical development studies. The other biosimilar to adalimumab is Amgen’s Amjevita (adalimumab-atto).
Benznidazole Approved as First U.S. Treatment for Chagas Disease
There may be approximately 300,000 persons in the United States with Chagas disease Read More...
This week the FDA granted accelerated approval to benznidazole as the first treatment for children ages 2 to 12 years old with Chagas disease. Chagas disease, or American trypanosomiasis, is a parasitic infection caused by Trypanosoma cruzi contracted from certain insect feces, blood transfusions, or from mother-to-child during pregnancy. After years of infection, the disease can cause serious heart illness, and it also can affect swallowing and digestion. In studies, 55% to 60% of children had an antibody test change from positive to negative compared with 5% to 14% on placebo. Common side effects include stomach pain, rash, decreased weight, headache, and nausea, among others.
FDA Approves Gocovri for the Treatment of Parkinson's Disease Dyskinesia
Gocovri is a high dose 274 mg amantadine (equivalent to 340 mg amantadine HCl) taken once-daily at bedtime Read More...
The FDA has approved Gocovri (amantadine), from Adamas Pharmaceuticals, an extended release capsule formulation for treatment of dyskinesia in patients with Parkinson's disease (PD) receiving levodopa-based therapy, with or without dopaminergic medications. Gocovri is the first PD medicine shown in controlled trials to reduce both dyskinesia and off time in patients receiving levodopa. Dyskinesias are involuntary movements that occur due to levodopa-based Parkinson's disease treatment and can impact activities of daily living. In studies, a statistically significant reduction in the Unified Dyskinesia Rating Scale was seen compared to placebo: 37% vs. 12%, respectively, at Week 12 in study 1, and 46% vs. 16% in study two.
Vabomere Clears FDA for Complicated Urinary Tract Infections
Vabomere should be used only for infections that are proven or strongly suspected to be caused by susceptible bacteria Read More...
The FDA has approved intravenous Vabomere (meropenem and vaborbactam) for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere contains meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria. In studies with 545 adults with cUTI, including those with pyelonephritis, roughly 98% of patients treated with Vabomere had a cure or improvement in symptoms and a negative urine culture test. The most common adverse reactions in patients taking Vabomere were headache, infusion site reactions and diarrhea, among others.