Drugs

Accelerated Approval for Brukinsa for Some Lymphomas

FDA has granted accelerated approval to BeiGene USA’s Brukinsa (zanubrutinib) with obintuzumab (Genentech’s Gazyva) for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. An agency notice says the regimen was evaluated in a trial of 217 patients. Efficacy was based on the overall response rate and duration of response, it says.

The most common adverse reactions included decreased neutrophil counts and platelet counts, upper respiratory tract infection, hemorrhage, and musculoskeletal pain. Serious adverse reactions occurred in 35% of patients who received the Brukinsa plus Gazyva regimen, the notice says.

FDA says its review used the Assessment Aid, a voluntary submission from the applicant to facilitate the agency assessment. The application received fast-track and orphan drug designations.

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