Drugs

FDA Approves Expanded Label for Janssen’s Imbruvica

FDA has approved an expanded label for Janssen’s Imbruvica (ibrutinib) based on data supporting its use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The approved label now includes overall survival data from the Phase 3 RESONATE-2 (PCYC-1115) trial in treatment-naïve CLL/SLL patients 65 years or older. It also contains clinical data from the Phase 3 HELIOS (CLL3001) trial investigating the use of Imbruvica in combination with bendamustine and rituximab versus placebo plus rituximab in patients with relapsed or refractory CLL/SLL.

The company says the updated data reflect a statistically significant 56% reduction in the risk of death with Imbruvica compared to chlorambucil after a median follow-up of 28.1 months. Additionally, data added to the label show improvement in progression-free survival and overall response rate when using Imbruvica plus rituximab versus placebo plus rituximab in patients with relapsed/refractory CLL/SLL.

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

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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

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome