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  • 'Zongertinib' for HER2-mutant NSCLC receives ODD
  • by Lee, Tak-Sun | translator Hong, Ji Yeon | Nov 5, 2025 06:25am
MFDS notifies of the orphan drug designation (ODD)¡¦accelerated preparation for official approval
Unlike Enhertu, an intravenous injectable, zongertinib increased administration convenience as a tablet formulation
 ¡ã Boehringer Ingelheim
Boehringer Ingelheim's 'zongertinib,' the first oral targeted therapy for patients with HER2-mutant non-small cell lung cancer (NSCLC) and which is gaining attention, received Orphan Drug Designation (ODD) from the Ministry of Food and Drug Safety (MFDS).

The designation of the drug as an orphan drug is expected to accelerate its official approval, as it provides benefits such as support for approval, fee exemptions, and extended priority status.

On November 4, the MFDS announced the designation of zongertinib as an orphan drug for the "treatment of progressive, unresectable, or metastatic non-squamous NSCLC patients with HER2 mutation."

A drug qualifies as an orphan drug if the number of patients in Korea is
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