Drugs

FDA Not Keeping Pace with Non-Oncology Basket Trials: Column

An online Clinical Trial Vanguard post says FDA has not kept pace with the advancing science of oncology-based basket trials migrating into non-oncology drug trials. “FDA’s guidance on master protocols, covering basket, umbrella, and platform trials, was finalized in 2022 and is explicitly anchored to oncology use cases,” the post says…. “The problem is that FDA’s current guidance on master protocols offers sponsors limited specific direction on how to handle cross-population safety signal adjudication when adverse event profiles differ meaningfully across baskets.”

The 2022 guidance says that sponsors should consult with the relevant review division early in development to discuss the basket trial design, the post says. “That sentence is doing an enormous amount of work,” it continues. “It is, functionally, an acknowledgement that the guidance itself is incomplete, and that the real regulatory framework for any given basket trial will be negotiated in Type B meetings, not derived from published doctrine.”

The article cautions that sponsors who view the consultation sentence as reassurance are misreading it. “Sponsors who treat it as a starting gun for early engagement, submitting detailed basket design rationales in pre-IND meetings before a single patient is enrolled, will build the precedent that eventually becomes the guidance update the field actually needs,” it concludes. “Within 18 months, the first NDA or BLA submission on a non-oncology basket trial Phase 1 foundation will force FDA’s hand. Either the agency will accept the cross-basket safety synthesis as sufficient for Phase 2 dose selection, establishing a workable precedent, or it will issue a Complete Response Letter that resets the field’s expectations about what basket architecture can carry into registration. The sponsors who have already had those Type B communications will be protected. The ones relying on the 2022 guidance to do the regulatory heavy lifting will not be ready for what comes back.”

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