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Key Takeaways for Pharmacists
This article discusses the FDA’s awarding of National Priority Vouchers to two drugs: Enlicitide Decanoate and Sacituzumab Tirumotecan. These vouchers are designed to accelerate the review and approval process, meaning pharmacists should prepare for potential rapid integration of these therapies into practice.
1.enlicitide decanoate (Oral PCSK9 Inhibitor)
* What it is: An oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor.This is meaningful as it could be the first oral PCSK9 inhibitor available.
* Indication: Hypercholesterolemia, heterozygous familial hypercholesterolemia (HeFH), or statin intolerance.
* Clinical Trial Data (CORALreef trials):
* Demonstrated statistically significant LDL-C reductions (around 55-61.5% reduction) compared to placebo in patients with atherosclerotic cardiovascular disease and HeFH.
* Reductions were observed as early as week 4.
* Pharmacist Implications: Be prepared for a new oral option for LDL-C lowering,potentially increasing accessibility for patients who can’t tolerate statins or need substantial LDL-C reduction.
2. Sacituzumab Tirumotecan (Sac-TMT)
* What it is: A TROP2-directed antibody-drug conjugate (ADC).
* Indication: Previously treated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR mutations.
* Clinical trial Data (OptiTROP-Lung04):
* Improved progression-free survival (PFS) - 8.3 months with Sac-TMT vs. 4.3 months with chemotherapy (HR 0.49).
* Improved overall survival (OS) – statistically significant enhancement (HR 0.60, *P* = .001).
* Pharmacist Implications: Stay current on emerging antibody-drug conjugates and evolving treatment pathways for NSCLC. This drug addresses a significant unmet need in EGFR-mutated NSCLC after progression on EGFR-TKI therapy.
3. National Priority Voucher Program – General Implications
* Accelerated Review: The FDA’s use of these vouchers signals a faster approval process for therapies addressing critical needs.
* Program Status: 18 products have received a voucher under the program since its establishment in June 2025.
* FDA Commissioner’s Statement: The FDA is focused on improving the accessibility and affordability of healthcare.
In essence, this article highlights two potentially impactful new therapies and emphasizes the need for pharmacists to stay informed about emerging treatments and accelerated approval pathways.
