Drugs

Hold on Allogene CAR T Trial Over Chromosomal Abnormality

FDA has placed a clinical hold on Allogene Therapeutics clinical trials involving Allo-501A CAR T cells after a report of a chromosomal abnormality in the company’s ALPHA2 study. The abnormality, which was detected in a bone marrow biopsy undertaken to assess pancytopenia (low blood counts), was reported to the agency. “An investigation is underway to further characterize the observed abnormality, including any clinical relevance, evidence of clonal expansion, or potential relationship to gene editing,” the company says.

The case involves a patient with Stage IV transformed follicular lymphoma and c-myc rearrangement whose cancer was refractory to two prior lines of immune-chemotherapy and additional radiation therapy, according to Allogene. Following infusion of Allo-501A, the patient subsequently developed progressive pancytopenia and a bone marrow biopsy showed aplastic anemia and the presence of Allo-501A CAR T cells with the chromosomal abnormality, it says

Allogene says that early translational data “showed that the CAR T cells expanded, peaking on Day 28, and undergoing contraction thereafter. The patient had a partial response to Allo-501A and subsequently underwent allogeneic stem cell transplantation. Prolonged cytopenia requiring rescue stem cell transplantation has been reported in autologous CAR T therapies.”

Allogene says it will provide additional updates in the coming weeks following consultation with FDA. The agency continues to actively review end-of-Phase 1 materials submitted in anticipation of an ALLO-501A pivotal Phase 2 trial, 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