Drugs

Consider Oncology Single-Arm Trial Issues: CDER

CDER researchers say that while the use of single-arm oncology trials has allowed for transformative oncology therapies to be made available to patients expeditiously, using such trials to support drug approval presents several challenges that must be carefully considered. Writing in JAMA Oncology, the researchers say that between 1/1/2002 and 12/31/2021, FDA granted 176 new malignant hematology and oncology indications based on single-arm trials, including 116 accelerated approvals and 60 traditional approvals.

Identifying the optimal drug dose in a single-arm trial remains challenging, the researchers say. The lack of a comparator arm may make identifying a comparative data set to use for the presumed response rate in a historical control difficult. And there is no standard for what constitutes clinically relevant thresholds for durable response rates and points.

The article concludes that while single-arm trials continue to demonstrate their use as a valuable tool to evaluate and approve cancer therapies, randomized clinical trials remain the preferred approach in clinical investigation and are the preferred design to support the approval of new anticancer therapies.

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