Boehringer Ingelheim, a Germany-based biopharmaceutical company, announced on Friday that it has received a Commissioner's National Priority Voucher (CNPV) for HERNEXEOS (zongertinib tablets).
HERNEXEOS is currently under investigation for first-line use in treatment-naive patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC).
The CNPV program looks to reduce the review process from a typical tome-scale of 10-12 months to one to two months, while maintaining the FDA's rigorous safety and efficacy standards.
This honour is claimed to reflect the potential of HERNEXEOS to meet critical patient requirements for this rare and aggressive cancer.
The FDA chose HERNEXEOS for the CNPV program.
TransThera publishes clinical results from US-based Phase 2 trial of tinengotinib in CCA
Orano Med and Roche advance pretargeted radioimmunotherapy into clinical phase
OncoPrecision's ONC001 data selected for presentation at 67th ASH Annual Meeting and Exposition
Immedica gets UAE approval for Zepzelca maintenance treatment
Imugene Ltd enters co-development collaboration with JW Therapeutics (Shanghai)
Mendus reports trial follow-up data supporting potential of vididencel in high-risk ovarian cancer
SK Biopharmaceuticals signs licence agreement with Wisconsin Alumni Research Foundation
GE HealthCare receives FDA clearance for AI-powered Pristina Recon DL mammography system