The US FDA Accepts NDA of Boehringer Ingelheim’s Zongertinib for HER2 (ERBB2)-Mutant NSCLC
Shots:
- The US FDA has accepted & granted priority review to the NDA of zongertinib (BI 1810631) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy (PDUFA: Q3’25)
- Submission was based on P-Ib (Beamion LUNG-1) trial assessing zongertinib as Monotx. in 2 arms (Arm 1: solid tumors with HER2 alterations, unresponsive to previous therapy & Arm 2: NSCLC with specific HER2 mutation) that showed improved ORR of 71%, with 6mos. PFS of 69% & DoR rate of 73% in Arm 1 (n=75)
- Zongertinib is being evaluated in an ongoing P-III (Beamion LUNG-2) trial assessing it vs SoC in above mentioned pts
Ref: Boehringer Ingelheim | Image: Boehringer Ingelheim
Related News:- Boehringer Ingelheim Launches Semintra in the EU to Treat Feline Hypertension
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
