In today's ACT Brief, we examine how AI enables sponsors to pressure-test protocols before enrollment, HHS's multi-initiative effort to accelerate trial design and execution, and FDA approval expanding heart disease therapy to adolescents.
News|Podcasts|December 10, 2025
ACT Brief: New CAR-T Trial Requirements, Pfizer Advances Oral GLP-1 Strategy, and Kisqali Shows Durable Long-Term Control
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we break down FDA’s new superiority requirement reshaping CAR-T development, examine Pfizer’s global move into oral small-molecule GLP-1 therapy, and highlight new MONALEESA findings that reinforce long-term disease control with Kisqali.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- The FDA has
introduced a significant shift in its expectations for future CAR-T approvals, outlining that new therapies will generally need to demonstrate superiority to standard treatments in randomized trials rather than relying on single-arm designs. Earlier this year, the agency eliminated REMS reporting requirements for approved CAR-Ts, reducing administrative and logistical burdens for treatment centers while shortening monitoring periods for patients—changes that will meaningfully influence trial design, evidence generation, and operational planning across the cell therapy landscape. - Pfizer
announced an exclusive global collaboration and license agreement with Yao Pharma for YP05002, an oral small-molecule GLP-1 agonist currently in Phase I for chronic weight management. Under the agreement, Yao will complete its ongoing early-phase studies, while Pfizer assumes global development, manufacturing, and commercialization—strengthening the company’s expanding cardiometabolic pipeline and positioning the asset for potential combination strategies within its broader obesity portfolio. - And as new clinical data continue to shape long-term expectations in oncology, a pooled
analysis of MONALEESA trials presented at the San Antonio Breast Cancer Symposium shows that roughly one in four patients on first-line Kisqali achieve disease control beyond four years. The findings reinforce Kisqali role as a cornerstone therapy in HR+/HER2– advanced breast cancer while underscoring the need for resourcing models that accommodate longer treatment durations and sustained follow-up in modern oncology programs.
That’s all for today’s ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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