Expanded Label Officially Makes Bempedoic Acid a CVD Prevention Medication
The FDA approved label expansions for bempedoic acid (Nexletol) and bempedoic acid/ezetimibe (Nexlizet) so they can be used more broadly as cardiovascular prevention drugs, Esperion announced Friday. Based on the CLEAR Outcomes trial, the two adenosine triphosphate (ATP) citrate lyase inhibitor drugs are now indicated for adults with either established atherosclerotic cardiovascular disease (CVD) or […]
Pediatric Neuron Disease Gets Its First Gene Therapy
The FDA approved atidarsagene autotemcel (arsa-cel; Lenmeldy), the first gene therapy to treat children with pre-symptomatic late infantile, pre-symptomatic early juvenile, or early symptomatic early juvenile metachromatic leukodystrophy (MLD), the agency announced on Monday. “This is the first FDA-approved treatment option for children who have this rare genetic disease,” Peter Marks, MD, PhD, director of […]
First-Line Nivolumab Plus Chemo Approved for Bladder Cancer
The FDA approved the PD-1 immune checkpoint inhibitor nivolumab (Opdivo) in combination with cisplatin and gemcitabine for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma, the agency announced Thursday. Approval was based on results from the phase III CheckMate-901 trial, which were presented last year at the European Society for Medical Oncology […]
FDA Approves Antibiotic Combination for Complicated UTIs
The FDA approved the combination of cefepime and enmetazobactam (Exblifep) for the treatment of adult patients with complicated urinary tract infections, including pyelonephritis. The agency’s decision was based on data from the phase III ALLIUM trial in which the β-lactam/β-lactamase inhibitor combination demonstrated superiority over piperacillin/tazobactam. Clinical efficacy was shown for Pseudomonas aeruginosa and among […]
FDA OKs First Cellular Therapy for Melanoma
The FDA approved the cellular therapy lifileucel (Amtagvi) for the treatment of patients with previously treated unresectable or metastatic melanoma, the agency announced Friday. Lifileucel, a cellular therapy with tumor-infiltrating lymphocytes (TILs), was approved through the accelerated approval pathway, and is the first FDA-approved tumor-derived T-cell immunotherapy, the FDA noted. “Unresectable or metastatic melanoma is […]
FDA Approves Florida’s Proposal to Import Prescription Drugs From Canada
The FDA on Friday approved a plan by the state of Florida to allow direct importation to the state of drugs from Canada, many of which are expected to be at a much lower cost than the same drugs procured in the U.S. “The FDA may authorize … proposals from states or Indian tribes to […]
FDA Approves New Agent for Nerve Pain From Rare Inherited Disease
Eplontersen (Wainua) was approved by the FDA to treat polyneuropathy associated with hereditary transthyretin-mediated amyloidosis (ATTR) in adults, Ionis Pharmaceuticals and AstraZeneca announced on Thursday. Hereditary ATTR is caused by a mutation in the TTR gene that results in the buildup of misfolded transthyretin protein, leading to amyloid deposits in the peripheral nerves (ATTR-PN) or […]
Clinical Challenges: Using Pola-R-CHP for Diffuse Large B-Cell Lymphoma
Earlier this year, the FDA approved a new frontline option for patients with diffuse large B-cell lymphoma (DLBCL): the antibody-drug conjugate polatuzumab vedotin (Polivy) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP). Combination chemotherapy involving rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) — and before that, CHOP alone — has been the established option […]
Tirzepatide Wins FDA Approval for Weight Loss
The FDA approved tirzepatide (Zepbound), the latest injectable for chronic weight management in adults, the agency announced on Wednesday. The combination glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist is indicated for adults with obesity or overweight with at least one weight-related condition, alongside a reduced-calorie diet and increased physical activity. Eli Lilly’s […]
First Multiple Sclerosis Biosimilar Approved
The first biosimilar for multiple sclerosis (MS) was approved, the FDA announced late Thursday. Natalizumab-sztn (Tyruko) was approved as a biosimilar to natalizumab (Tysabri) injection to treat clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS, the agency said. Like its reference biologic, natalizumab-sztn (previously called PB006) also was approved to treat certain adult […]