Drugs

BeiGene Gets Fast Track on Leukemia Therapy

FDA has granted BeiGene a fast track designation for BGB-16673 and its use in adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have been previously treated with at least two prior lines of therapy, including a Bruton’s tyrosine kinase (BTK)-inhibitor and a B-cell lymphoma 2 inhibitor.

The designation was based on the potential for BGB-16673 to address an unmet medical need for patients CLL/SLL whose disease has progressed. “Data from ongoing first-in-human Phase 1/2 (NCT05006716) presented at the European Hematology Association 2024 Hybrid Congress in June highlighted the tolerable safety and promising efficacy in heavily pretreated patients with R/R CLL/SLL,” the company says. To date, more than 300 patients have been treated in 15 countries across the BGB-16673 global clinical development program, it adds.

CLL is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes flood peripheral blood, bone marrow, and lymphoid tissues. BGB-16673 is described as an orally available BTK-targeting chimeric degradation activation compound designed to induce degradation of wildtype and multiple mutant forms of BTK, including those that commonly confer resistance to BTK inhibitors in patients who experience progressive disease.

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