Drugs

Athenex Cell Therapy on Clinical Hold

FDA has issued a clinical hold against Athenex and Baylor College of Medicine’s kUR-501, an autologous GD2 CAR-NKT cell therapy for relapsed/refractory high-risk neuroblastoma (R/R HRNB), after a young heavily pretreated male patient died. The death came after treatment at the fifth dose level of 300 million cells/m2 about three weeks after CAR-NKT cell therapy product administration. “Baylor College of Medicine (BCM), the IND holder, continues to investigate the etiology and pathogenesis of this event,” the company says.

GD2 is a molecule expressed on most neuroblastomas, and on some other tumors, with restricted expression on normal tissues, which makes it an ideal target for CAR-NKT cell therapy, Kuur says. It is developing KUR-501 for treating of high risk, relapsed, refractory neuroblastoma in children.

Athenex says the patient was “found to have human metapneumovirus infection, then Grade 1 cytokine release syndrome (CRS) that was treated with immunosuppressants.” He later developed polyclonal hyperleukocytosis complicated by multiorgan dysfunction without evidence of sepsis.

BCM is putting together a safety risk mitigation plan to reopen the clinical trial, Athenex says, which could exclude patients with concomitant viral infections. The company says it is also working closely with BCM to help address FDA’s questions.

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