- FDA awards Priority Voucher to zongertinib for HER2-mutant NSCLC.
- Review process reduced from 10-12 months to 1-2 months.
- Boehringer plans a supplemental New Drug Application for first-line treatment.
- Zongertinib previously received Breakthrough Therapy Designation.
FDA Priority Voucher
The U.S. Food & Drug Administration (FDA) has awarded a Commissioner’s National Priority Voucher (CNPV) to zongertinib for treating patients with HER2-mutant non-small cell lung cancer (NSCLC). This voucher aims to expedite the review process from the usual 10-12 months to 1-2 months, while maintaining the FDA's safety and efficacy standards.
Supplemental New Drug Application
Boehringer Ingelheim plans to submit a supplemental New Drug Application (sNDA) for zongertinib as a first-line treatment for patients with HER2-mutant NSCLC. This step follows the FDA's nomination of zongertinib for the CNPV program.
Previous Designation
Zongertinib has previously been granted Breakthrough Therapy Designation by the FDA for use in a first-line setting, highlighting its potential in addressing critical patient needs for this rare and aggressive cancer.
