FDA Policy/General

Panel to Mull Stomach/Esophagus Cancer Therapies

Federal Register notice: FDA is announcing a 9/26 Oncologic Drugs Advisory Committee meeting to discuss the use of immune checkpoint inhibitors in patients with unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma. The agency intends to seek panel feedback on the following:

adequacy of PD-L1 expression as a predictive biomarker for patient selection in this patient population;
differing risk-benefit assessments in different subpopulations defined by PD-L1 expression; and
adequacy of the cumulative data to restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression.

Panel members are also scheduled to discuss existing supplemental BLAs that were approved for patients with previously untreated HER2-negative unresectable or metastatic gastric or gastroesophageal adenocarcinoma. Additionally, they will discuss a BeiGene BLA for tislelizumab injection for the same proposed indication. And in the afternoon session, members will discuss the use of immune checkpoint inhibitors in patients with metastatic or unresectable esophageal squamous cell carcinoma. To view the notice, click here.

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