Drugs

FDA Lifts Hold on Multiple Myeloma Drug

FDA has lifted a two-month-long partial clinical hold on a Molecular Templates (MTEM) Phase 1 multiple myeloma study of MT-0169 that was based on previously disclosed cardiac adverse events noted in two patients dosed at 50 mcg/kg, which prompted a dose reduction from 50 mcg/kg to 5 mcg/kg last year, according to the company. “Since then, four patients have been dosed at 5 mcg/kg and three patients have been dosed at 10 mcg/kg with no cardiac adverse events noted,” the company said at the time of the hold.

Regarding the patients dosed at 50 mcg/kg, one experienced asymptomatic Grade 2 myocarditis and the other experienced asymptomatic Grade 3 cardiomyopathy, the company says, adding that both patients had full recoveries within two months. To lift the hold, FDA had asked MTEM to “provide narratives on the two patients who experienced cardiotoxicity at 50 mcg/kg, justification for the revised dose of 5 mcg/kg, and data evaluating the clinical benefit-to-risk ratio seen with the lower doses of MT-0169, among other requests,” it added.

Removal of the hold allows MTEM to evaluate the efficacy of MT-0169, one of its engineered toxin bodies which specifically targets CD38, a validated target in multiple myeloma, the company says. “MT-0169 represents a novel approach to myeloma that is demonstrating good safety with early signs of potential clinical benefit, particularly in the extramedullary setting, where we have seen a stringent Complete Response in a patient who remains on study for 10 months,” it says.

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