FDA Grants National Priority Vouchers to Enlicitide Decanoate, Sacituzumab Tirumotecan

The FDA has announced the awarding of 2 national priority vouchers to the investigational products enlicitide decanoate (Merck & Co.) and sacituzumab tirumotecan (sac-TMT; Merck & Co.), according to a news release from the agency.¹

The vouchers, awarded under the Commissioner’s National Priority Voucher (CNPV) pilot program, are designed to accelerate the review and approval of novel products that could address key national priorities, including addressing a large unmet medical need or increasing accessibility and affordability. The program was established in June 2025; since then, 18 products have received a voucher under the CNPV pilot program.¹

“High health care costs and prescription drug prices threaten to undermine all the technological advancements we see in the medical field,” Marty Makary, MD, MPH, FDA Commissioner, said in the news release. “We’re pleased to grant these vouchers to 2 products that may significantly contribute to our goal of improving the accessibility and affordability of health care in America.”¹

About the Products Awarded National Priority Vouchers

Enlicitide Decanoate

Enlicitide decanoate is an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor designed to reduce low-density lipoprotein cholesterol (LDL-C). It could potentially become the first approved oral PCSK9 inhibitor for patients with hypercholesterolemia or heterozygous familial hypercholesterolemia (HeFH). Multiple phase 3 clinical trials, recently presented at the 2025 American Heart Association Scientific Sessions, demonstrated the safety and efficacy of enlicitide decanoate in these populations.²

The randomized, double-blind, placebo-controlled CORALreef Lipids trial (NCT05952856) evaluated enlicitide decanoate in adults with or at risk for atherosclerotic cardiovascular disease on background lipid-lowering therapies or those with documented statin intolerance.²

Enlicitide decanoate demonstrated statistically significant reductions in LDL-C at week 24 compared with placebo (55.8%; 95% CI, –60.9 to –50.7, P < .001). Key reductions were also observed in non-high-density lipoprotein cholesterol (non-HDL-C), apoprotein B (ApoB), and lipoprotein A (Lp[a]). Meaningful reductions in LDL-C were consistently reported 1 year into treatment according to the primary study analysis (47.6%; 95% CI, –52.7 to –42.5, P < .001).²

In CORALreef HeFH (NCT05952869), a randomized, double-blind, placebo-controlled, multicenter trial, investigators focused on patients with HeFH, a genetic disorder that leads to abnormally high LDL-C levels. In the trial, patients treated with enlicitide decanoate achieved meaningful reductions in LDL-C at week 24 compared with placebo (59.4%; 95% CI, –65.6 to –52.2, P < .001). Once more, positive reductions were observed in non-HDL-C, ApoB, and Lp[a].²

CORALreef HeFH investigators observed LDL-C reductions as early as week 4 of the trial. At the 1-year mark, significant reductions in LDL-C with enlicitide decanoate were observed compared with placebo (61.5%; 95% CI, –69.4 to –53.7, P < .001).²

The positive developments across the CORALreef clinical trial program signify the potential of enlicitide decanoate, as an oral, once-daily pill, to transform cholesterol management for millions if the treatment is granted FDA approval.²

Sacituzumab Tirumotecan

Sac-TMT is a trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate. It is being investigated for the treatment of certain patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with EGFR mutations.¹

Researchers have demonstrated the effectiveness and safety of sac-TMT in patients with EGFR-mutated NSCLC that has progressed following prior EGFR-tyrosine kinase inhibitor therapy. In the OptiTROP-Lung04 clinical trial (NCT05870319), sac-TMT successfully improved progression-free survival (PFS) and overall survival outcomes compared with platinum-based chemotherapy.³

In the trial, which randomized 376 patients (n = 188 for each group), patients treated with sac-TMT had a median PFS of 8.3 months at the median follow-up of 18.9 months, compared with 4.3 months in the chemotherapy group (hazard ratio [HR] for disease progression or death, 0.49; 95% CI, 0.39 to 0.62). OS was meaningfully longer with sac-TMT than with chemotherapy (HR, 0.60; 95% CI, 0.44 to 0.82; P = .001).³

Sac-TMT was previously granted breakthrough therapy designation by the FDA. This designation, taken together with the national priority voucher award, bolsters the regulatory pathway towards approval for sac-TMT. If approved, the drug could fill a major unmet need for patients with advanced or metastatic NSCLC harboring EGFR mutations, who currently do not have many available treatment options.^1,4

REFERENCES

1. FDA grants two national priority vouchers. FDA. News Release. Released December 19, 2025. Accessed January 7, 2026. https://www.fda.gov/news-events/press-announcements/fda-grants-two-national-priority-vouchers

2. Halpern L. New enlicitide decanoate data show significant LDL-C reductions in at-risk patients. Pharmacy Times. Published November 19, 2025. Accessed January 7, 2026. https://www.pharmacytimes.com/view/new-enlicitide-decanoate-data-show-significant-ldl-c-reductions-in-at-risk-patients

3. Fang W, Wu L, Meng X, et al. Sacituzumab tirumotecan in EGFR-TKI-resistant, EGFR-mutated advanced NSCLC. N Engl J Med.