Drugs

BMS Breyanzi ‘Deep and Durable Efficacy’

Bristol Myers Squibb says its Breyanzi (lisocabtagene maraleucel) showed “deep and durable efficacy” in the Phase 1/2 TRANSCEND CLL 004 study of adults with relapsed or refractory lymphocytic leukemia or small lymphocytic lymphoma. A company statement says Breyanzi delivered statistically significant complete response rates, the primary endpoint, in 18.4% of patients in the primary efficacy analysis. Among patients who achieved a complete response, it says, no disease progression or deaths were observed, with the median duration of response not reached.

Breyanzi is described as CD-19 directed CAR T cell therapy with a 4-1BB costimulatory domain. It is approved by FDA to treat large B-cell lymphoma, including certain patients with diffuse large B-cell lymphoma. It is not indicated to treat patients with primary central nervous system lymphoma.

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