Drugs

BeiGene’s Brukinsa OK’d for Marginal Zone Lymphoma

FDA has granted accelerated approval for BeiGene’s Brukinsa (zanubrutinib) for treating adult patients with relapsed or refractory marginal zone lymphoma who have received at least one anti-CD20-based regimen. Approval is based on efficacy data from two single-arm clinical trials, with overall response rate (ORR) as the primary endpoint, according to the company.

In the Phase 2 MAGNOLIA trial (NCT03846427), 66 patients were evaluated. Based on assessment using CT scanning, the ORR was 56% with a complete response (CR) rate of 20%. In the Phase 1/2 trial BGB-3111-AU-003 (NCT02343120), a total of 20 patients were assessed. Based on an assessment using CT scanning, the ORR was 80% with a CR rate of 20%.

BeiGene says Brukinsa is a small molecule inhibitor of Bruton’s tyrosine kinase that is currently being evaluated globally for treating B-cell malignancies, according to the company. It was approved 11/2019 for mantle cell lymphoma in adult patients who have received at least one prior therapy.

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