FDA Grants Priority Review to Zongertinib for HER2-Mutated NSCLC

The FDA has granted Priority Review to the New Drug Application for zongertinib (BI 1810631) for the treatment of adults with unresectable or metastatic non–small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) mutations and who have received prior systemic therapy, according to an announcement from Boehringer Ingelheim.

The Prescription Drug User Fee Act (PDUFA) action date is in the third quarter of 2025, officials said. If approved, zongertinib would be the first orally administered, targeted therapy for patients with previously treated HER2-mutated advanced NSCLC, according to the announcement.

“We believe zongertinib has the potential to transform the care of previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer and are hopeful about the continued research in other tumor types and lines of therapy,” Shashank Deshpande, member of the board of managing directors and head of Human Pharma at Boehringer Ingelheim, said in a statement. “Priority Review illustrates the urgent need in this patient population and the possibility for zongertinib to be a groundbreaking innovation for patients with limited treatment options.”

The application was based on results from the phase 1b Beamion LUNG-1 trial, which showed an objective response rate of 71% with a 6-month progression-free survival rate of 69% in patients with mutations in the region encoding the HER2 tyrosine kinase domain (cohort 1, n=75). The 6-month duration of response rate was 73%.

“Personalized medicine has revolutionized cancer treatment,” GO2 for Lung Cancer’s chief scientific officer, Courtney Granville, said in a statement. “Early screening and biomarker testing for mutations provide critical information to guide targeted therapies in personalized medicine. This filing acceptance represents a significant step toward offering another option for individuals with a HER2 (ERBB2) diagnosis, bringing hope and direction to cancer patients.”

The safety profile of zongertinib showed a “low incidence” of dose reactions (5%) and treatment discontinuations (3%), according to officials, who noted that the “majority” of treatment-related adverse events (TRAEs) with zongertinib were “mild in nature,” with diarrhea (51%) and rash (27%) being the most common all-grade TRAEs. No new safety signals were reported, and no treatment-related interstitial lung disease cases were reported. Grade 3 or higher TRAEs occurred in one patient who received treatment with zongertinib.

Zongertinib was previously granted Breakthrough Therapy designation and Fast Track designation by the FDA. In addition to the FDA designations, Japan’s Pharmaceuticals and Medical Devices Agency recently granted Orphan Drug designation to zongertinib, officials said.

Source: PR Newswire