Words by GOLD newsdesk
The FDA has granted Priority Review to Boehringer Ingelheim’s new drug application for its non-small cell lung cancer (NSCLC) therapy zongertinib.
The specific indication is for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours harbour HER2 (ERBB2) mutations after prior systemic therapy. In terms of timelines, the designation accelerates review to six months.
Commenting in a press release, Shashank Deshpande, Member of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim, said that the review choice “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 for the investigational treatment is supported by Phase Ib clinical trial data, where the drug demonstrated an objective response rate of 71% in 75 previously treated patients with advanced NSCLC. If approved, it would be the first targeted therapy taken orally for patients who meet the specified indication requirements.
“Personalised medicine has revolutionised cancer treatment,” commented Courtney Granville, Chief Scientific Officer, GO2 for Lung Cancer. “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 drug has already received Breakthrough Therapy and Fast Track designations from the FDA, which is awarded to innovations set to treat a serious or life-threatening disease. It has also recently received Orphan Drug Designation from Japan’s Pharmaceuticals and Medical Devices Agency.
