Drugs

Hold Lifted on Arcellx Myeloma Drug

FDA has lifted a partial clinical hold against an Arcellx IND for CART-ddBCMA, an investigational drug for treating patients with relapsed or refractory multiple myeloma. The hold was ordered in June following a recent patient death. At the time, the company said it believed “limitations on bridging therapy are a contributing factor and is working with FDA to amend the protocol to expand options for patients that are consistent with current clinical practice,” adding that other potential improvements to the study were being evaluated.

In announcing the hold’s removal, Arcellx says it updated the trial protocol, and FDA has allowed expanded bridging therapies, “which better aligns our protocol with current clinical practice. As a key step to enhancing protocol adherence related to the prevention and management of the risk of adverse events, we retrained clinical sites.”

Arcellx describes the therapy as a BCMA-specific CAR-modified T-cell therapy utilizing the company’s novel BCMA-targeting binding domain. It says it will present data from the Phase 1 study later this year as well as preliminary data from the iMMagine-1 study in the second half of 2024.

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