ACT Brief: Lilly Seeks FDA Priority Review for Oral GLP-1 as Bispecific Antibody Trials Redefine Ethical Standards

This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, highlight expert perspectives, and keep you current on what’s moving the industry.

We begin with a look at the growing promise—and complexity—of bispecific antibodies in cancer research.

A new feature article explores how these dual-targeting therapies are driving immuno-oncology innovation, with the global BsAb market projected to quadruple by 2030.

• The authors outline key mechanisms—such as T-cell engagement, dual checkpoint blockade, and receptor degradation—while warning that unique safety concerns, including cytokine release syndrome and neurotoxicity, require robust oversight.
• Institutional Review Boards are now central to maintaining ethical and regulatory compliance in these studies, as sponsors adopt biomarker-based selection, step-up dosing, and AI modeling to mitigate risk.
• With more than 650 BsAb trials expected by next year, this new era of engineered antibodies is pushing regulators, sponsors, and investigators to align safety innovation with accelerated oncology development.

Meanwhile, Eli Lilly is preparing to submit its once-daily oral GLP-1, orforglipron, to FDA’s national priority review program—an initiative designed to speed access to treatments addressing major health needs.

• The drug demonstrated an average 23-pound weight loss in Phase III trials, showing comparable efficacy to injectable GLP-1s.
• If accepted, orforglipron could become the first obesity therapy included in the program, signaling a potential strategic alignment with TrumpRx and positioning Lilly to redefine access and convenience in the global GLP-1 market.
• Industry analysts say the move underscores how obesity and cardiometabolic therapies are becoming national priorities, as regulators test new pathways for faster, more efficient approvals.

That’s all for today’s ACT Brief. Join us tomorrow for more insights shaping the future of clinical operations and drug development. Thanks for listening.