Drugs

FDA Seeks New Accelerated Approval Requirement

FDA may be raising the bar for sponsors seeking accelerated approval by requesting that they be “well underway with their Phase 3 confirmatory trial and ideally fully enrolled.” At least, that is the requirement the agency laid out for ADC Therapeutics during a meeting to discuss a potential accelerated approval BLA filing for Cami (camidanlumab tesirine) and its use in relapsed or refractory Hodgkin lymphoma (HL).

Requiring sponsors to have their confirmatory trials well underway at the time of initial submission was a goal FDA supported as an accelerated approval reform provision during the recent user fee reauthorization. It and other reform provisions were abandoned by lawmakers when they ran out of time as the user fee programs were set to expire 9/30 (see earlier story).

Last month, FDA commissioner Robert Califf revived his previous support for revamping the drug accelerated approval program. Delivering remarks at the 2022 National Organization for Rare Disorders (NORD) Breakthrough Summit in Washington, DC, Califf said improvements in the accelerated approval program are needed as soon as possible. Califf acknowledged then that the program’s biggest fault is probably companies being “too focused on just the acceleration and not enough on the evidence that’s needed to fill in that gap between when approval occurs and when you need the definitive evidence that the treatment fulfills its promise.” He said he supported user fee provisions, such as requiring sponsors to have a confirmatory trial underway at the time of approval, and additional authorities to more efficiently deal with companies who don’t fulfill their confirmatory evidence requirements.

In ADC’s case, the company met with agency officials in September to discuss a BLA based on recent Phase 2 data, which demonstrated an overall response rate of 70% and a complete response rate of 33%. After being presented with the confirmatory trial stipulations, the company says now it will not submit the BLA for Cami next year, as it is estimated that it would take at least two years to fully enroll a randomized confirmatory Phase 3 study. “The company is engaged with the FDA in an ongoing and constructive dialog regarding their guidance and the potential regulatory path forward,” it says. “At this time, the company is pausing any material investments in the HL program and will evaluate options for Cami in HL with a disciplined and strategic approach to resource allocation.”

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