Drugs

FDA OKs Breyanzi in 4th Lymphoma Use

FDA has approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel) for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. The. company says this is the fourth subtype of non-Hodgkin lymphoma for which the CD19-directed chimeric antigen receptor (CAR) T cell therapy is approved. In relapsed or refractory MCL, Breyanzi is delivered as a one-time infusion

Approval is based on results from the MCL cohort of TRANSCEND NHL 001, which enrolled adults with relapsed or refractory MCL who had previously received at least two or more prior lines of therapy, including a BTK inhibitor, according to the company. In patients treated with Breyanzi, 85.3% responded to treatment, with 67.6% seeing a complete response, it says, adding that responses were “rapid and durable with a median time to response of one month (range: 0.7-3) and median duration of response of 13.3 months (95% CI: 6.0-23.3) with a median follow-up of 22.2 months.”

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