Drugs

Imbruvica Indication Expanded to cGVHD

FDA has approved an expanded indication for Pharmacyclics’ Imbruvica (ibrutinib) to include chronic graft versus host disease (cGVHD) after failure of one or more treatments. The agency says it is the first approved therapy for treating cGVHD. Imbruvica, a kinase inhibitor, was previously approved for certain indications in treating chronic lymphocytic leukemia, Waldenström’s macroglobulinemia, and marginal cell lymphoma, as well as under accelerated approval status for mantle cell lymphoma.

Imbruvica’s efficacy and safety for treating cGVHD were studied in a single-arm trial of 42 patients with cGVHD whose symptoms persisted despite standard treatments with corticosteroids. In the trial, 67% of patients experienced improvement in their cGVHD symptoms. In 48% of trial patients, improvement of symptoms listed up to five months or longer, FDA says.

Common side effects of the drug in patients with cGVHD include hemorrhage, cytopenias, atrial fibrillation, hypertension, second primary malignancies, and tumor lysis syndrome. Women who are pregnant or breastfeeding should not take Imbruvica, the agency says, because it may cause harm to a developing fetus or newborn baby.

The drug’s application received priority review, breakthrough designation, and an orphan drug designation for this indication.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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

Read more

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

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome