Anti-CD20 Agent Gains Approval for Multiple Sclerosis
Ublituximab (Briumvi), a monoclonal antibody targeting CD20, was approved for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, TG Therapeutics announced. The FDA’s decision was based on two identical phase III trials of people with relapsing MS, ULTIMATE I and ULTIMATE II. At 96 weeks, ublituximab […]
Novel Capsid Inhibitor Approved for Super-Refractory HIV
The FDA approved lenacapavir (Sunlenca) in combination with antiretroviral therapy (ART) for heavily pretreated HIV-1 patients with drug-resistant infections, and for those who cannot tolerate other available options. Lenacapavir, a first-in-class long-acting HIV capsid inhibitor, is initially administered via oral tablets (300 mg) and subcutaneous shots (463.5 mg/1.5 mL), which are then followed by maintenance […]
FDA Approves First Gene Therapy for Non-Muscle-Invasive Bladder Cancer
The FDA has approved nadofaragene firadenovec (Adstiladrin) as the first gene therapy for the treatment of high-risk bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC), the agency announced on Friday. An adenoviral vector-based product, nadofaragene firadenovec, is specifically indicated for adult patients with carcinoma in situ (CIS) with or without papillary tumors. Approval was based on […]
FDA OKs First Gene Therapy for Hemophilia B
The FDA on Tuesday approved the first gene therapy for treating hemophilia B, a genetic bleeding disorder resulting from missing or insufficient levels of factor IX. Etranacogene dezaparvovec (Hemgenix) is indicated for adults with the condition who currently use factor IX prophylaxis therapy for blood clotting, those who have or have had life-threatening hemorrhage, or […]
Obesity drug helps teens lose weight, study finds
A drug called semaglutide, which is approved for adults with obesity or overweight, also helps adolescents shed pounds and have healthier hearts, according to a new study published today in the New England Journal of Medicine and presented at Obesity Week 2022. In an international phase 3a clinical trial, adolescents with obesity who received once-weekly […]
Three Adjuvant Immunotherapy Trials Flop in Renal Cell Carcinoma
PARIS — While pembrolizumab (Keytruda) has been approved as an adjuvant treatment for patients with high-risk renal cell carcinoma (RCC), three phase III studies presented at the European Society for Medical Oncology (ESMO) annual congress here failed to support the immune checkpoint inhibitor in this setting. In Part A of the CheckMate-914 trial, the median […]
First TYK2 Inhibitor for Psoriasis Wins FDA Approval
The FDA approved the first-in-class oral tyrosine kinase 2 (TYK2) inhibitor deucravacitinib (Sotyktu) for moderate-to-severe plaque psoriasis, Bristol Myers Squibb announced. The indication limits use to adults who are candidates for systemic therapy or phototherapy. Deucravacitinib is not recommended for use with other immunosuppressant drugs. “Sotyktu has the potential to become the new standard-of-care oral […]
Opinion | Virtual Reality Can Help Get Our Patients Vaccinated
Whether it is the newly approved COVID-19 vaccines or school-required immunizations, many children receive their mandatory shots over summer vacation. Estimates show that as many as two-thirds of children and one-fourth of adults have strong fears around needles. Despite the past few years’ extensive coverage of the political and cultural objections to vaccinations, procedural anxiety […]
First Treatment Approved for Eosinophilic Esophagitis
Dupilumab (Dupixent) became the first drug approved to treat eosinophilic esophagitis in adults and pediatric patients ages 12 and older weighing at least 40 kg (~88 lb), the FDA announced. Eosinophilic esophagitis is a chronic, progressive disease in which the esophagus becomes inflamed due to a buildup of eosinophils, creating difficulty swallowing and eating. Dupilumab […]
First GLP-1/GIP Receptor Agonist OK’d for Type 2 Diabetes
The FDA approved first-in-class tirzepatide (Mounjaro) for patients with type 2 diabetes, the agency announced on Friday. Tirzepatide, a glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide (GLP-1/GIP) agonist, is available at three dose levels (5 mg, 10 mg, and 15 mg), should be administered via injection once weekly, and is indicated as an adjunct to diet […]