The U.S. Food & Drug Administration (FDA) has awarded a Commissioner's National Priority Voucher (CNPV) for HERNEXEOS^® (zongertinib tablets), currently under investigation for first-line use in treatment-naïve patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC).  The CNPV program aims to shorten the review process from what normally takes 10-12 months to 1-2 months, while maintaining FDA's rigorous safety and efficacy standards.

"We are grateful to the FDA for this recognition and for the opportunity to bring HERNEXEOS, a potential new first-line treatment option, to patients with advanced HER2 NSCLC through the CNPV program, an innovative FDA pilot initiative," said Jean-Michel Boers, U.S. Country Managing Director, President and Chief Executive Officer, Boehringer Ingelheim USA. "As a company, we are proud to be among those leading the way in advancing science where the need is urgent. We commend the FDA for its innovative efforts to streamline review for medicines like HERNEXEOS, a breakthrough-designated therapy, so that they can reach patients as quickly as possible."

This recognition underscores the potential of HERNEXEOS to meet critical patient needs for this rare and aggressive cancer. HER2 (ERRB2) mutations are found in approximately 2-4% of NSCLC cases and are linked to poor prognosis.¹ The estimated 5-year survival rate historically has been less than 10% for metastatic disease. There remains a high unmet need for these patients as they have limited treatment options. ^2,3,4

Boehringer recently reported positive results from the Beamion LUNG-1 trial evaluating zongertinib in treatment-naïve patients with advanced NSCLC at ESMO 2025. The company is pursuing regulatory submission for HERNEXEOS as a first-line treatment.

The FDA nominated HERNEXEOS for the CNPV program. The FDA is currently reviewing the therapy under the Accelerated Approvalpathway and previously granted Breakthrough Therapy Designation for HERNEXEOS for use in a first-line setting.