National Priority Voucher from FDA for Sacituzumab Tirumotecan to accelerate the review of products with the potential to address key national priorities

FDA announced that it awarded two national priority vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program to two products under development by Merck: Enlicitide decanoate (an oral PCSK9 inhibitor for lowering LDL cholesterol) and Sacituzumab Tirumotecan (Sac-TMT, TROP2 ADC)

The CNPV pilot program offers an unprecedented opportunity to reduce drug and biological product application or efficacy supplement (ES) review times from 10-12 months to just 1-2 months, according to the FDA

• Previous vouchers for investigational products have been related to a specific indication. However, FDA’s announcement does not specify a particular indication for Sac-TMT’s voucher
• First approval for Sac-TMT is expected in 2L+ endometrial cancer. If CNPV is applied, an approval for Sac-TMT in this indication could happen as early as late Q1 2026 or early Q2 2026.

National Priority Voucher was awarded to these investigational products for their potential to increase access through affordability for American patients.

With these awards, 18 products have now received a voucher under the CNPV pilot program since it was announced in June 2025

Other investigational products to receive this voucher for an oncology indication include RMC-6236 for pancreatic cancer (Revolution Medicines), teclistamab for relapsed/refractory multiple myeloma (Johnson and Johnson), zongertinib for HER2 lung cancer (Boehringer Ingelheim), and dostarlimab for rectal cancer (GSK)

Additional information

The CNPV pilot program is designed to accelerate the review of products with the potential to address one or more of the following key national priorities: addressing a U.S. public health crisis, delivering more innovative cures for the American people, addressing a large unmet medical need, promoting domestic drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency, and increasing the accessibility and affordability of drugs and biologics

List of P3 studies with Sac-TMT initiated by Merck