The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Shots:China’s NMPA has granted conditional approval to Hernexeos (zongertinib) for treating pts with inoperable, locally advanced or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapyApproval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos alone, which showed improved ORR of 71% (N=75: 7% CR), mDoR of 14.1mos. & mPFS…

ByRidhi RastogiSeptember 1, 2025

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The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Shots:The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapyApproval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75% (N=71: 6% CR & 69% PR)…

ByRidhi RastogiAugust 11, 2025

NEWS

The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC

Shots:The US FDA has granted priority review to sevabertinib (BAY 2927088; reversible TKI) for the treatment of previously treated pts with advanced NSCLC harboring HER2 mutationsDesignation was based on the P-I/II (SOHO-01) trial assessing (20mg, BID, PO) in HER2-mutant NSCLC, with data previously reported from 2 cohorts: pts progressing on ≥1 systemic therapy who…

ByRidhi RastogiMay 29, 2025

The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC

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