Drugs

Clinical Hold Lifted on Zentalis’ Azenosertib

FDA has lifted a partial clinical hold on Zentalis Pharmaceuticals’ azenosertib studies, including a Phase 1 (ZN-c3-001) dose-escalation study in solid tumors, a Phase 2 (DENALI) study in platinum-resistant ovarian cancer, and a Phase 2 (TETON) study in uterine serous carcinoma. The June action was in response to two recent deaths due to presumed sepsis reported in the DENALI study.

“The FDA has cleared the company to resume enrollment in all ongoing azenosertib clinical studies with no changes in the clinical development plan,” the company says. “Zentalis will be working with clinical trial investigators to resume study activities across the azenosertib development program as quickly as possible.” It says a corporate event later this year will detail azenosertib monotherapy data and provide additional updates on the therapy’s clinical development.

Azenosertib is described as a novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in monotherapy and combination clinical studies in ovarian cancer and additional tumor types. “WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA,” Zentalis says. “By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.”

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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