Drugs

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing indications in certain cancers and active lupus nephritis.

Approval was based on data from the Phase 3 INSHORE study, a randomized, controlled, open-label trial involving 85 patients age 2 and older with childhood-onset frequently relapsing or steroid-dependent idiopathic nephrotic syndrome. Patients were required to be in complete remission when they entered the study.

Participants received intravenous Gazyva, with dosing based on weight, on Days 1 and 15 and Weeks 24 and 26, or twice-daily oral mycophenolate mofetil, a commonly used standard-of-care therapy. The study's primary endpoint was the proportion of patients with a first-morning urine protein-creatinine ratio of 0.2 g/g or less at Week 52 without experiencing a relapse between Weeks 8 and 52.

According to FDA, the proportion of patients meeting the endpoint was significantly greater with Gazyva than with standard-of-care treatment, with 73% of Gazyva-treated patients meeting the endpoint.

Idiopathic nephrotic syndrome is a kidney disorder of unknown cause characterized by substantial protein loss in the urine, which can result in low blood albumin and swelling. The condition can also cause high cholesterol, infections and blood clots. It is the most common cause of nephrotic syndrome in children and typically begins between ages 2 and 7. FDA estimates the annual incidence at one to four cases per 100,000 children.

Regarding safety, Gazyva carries a Boxed Warning for hepatitis B virus reactivation and progressive multifocal leukoencephalopathy, a rare and serious brain infection. The most common adverse reactions were infections, infusion-related reactions and neutropenia.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

Imfinzi sBLA Gets Priority Review for Bladder Cancer