Zongertinib 60 mg, 90 mg, 120mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 60 mg, 90 mg, 120mg

Reference Brands: Hernexeos (USA)

Category: Oncology Cancer Care

Zongertinib is an oral, small-molecule, irreversible tyrosine-kinase inhibitor that selectively targets the human epidermal growth factor receptor 2 (HER2/ERBB2) including certain activating mutations in the tyrosine-kinase domain. It is indicated for adult patients with unresectable or metastatic non-squamous NSCLC whose tumors harbor HER2 (ERBB2) tyrosine kinase domain activating mutations and who have previously received systemic therapy.

Product Description:

Zongertinib is an irreversible inhibitor selective for HER2, and the selectivity solves a long-standing problem. HER2 and EGFR are close relatives, so drugs aimed at HER2 have historically inhibited EGFR as well, producing rash and diarrhoea severe enough to prevent dosing at levels that would suppress HER2 properly. Sparing wild-type EGFR allows full target coverage at a dose patients can actually take.

It is used for unresectable or metastatic non-squamous non-small cell lung cancer with activating HER2 tyrosine kinase domain mutations, in patients who have had prior systemic therapy. These mutations occur in a small percentage of lung adenocarcinomas and, until recently, had no targeted oral option — the alternative was an antibody-drug conjugate carrying a risk of interstitial lung disease. Diarrhoea, rash and transaminase elevation are the main adverse effects, generally milder than with the non-selective inhibitors, and liver function is monitored.

Sourcing notes. Recently approved originator product, on patent, registered so far in a limited number of territories — confirm before quoting. Three tablet strengths support dose reduction. Requires HER2 mutation testing by next-generation sequencing, not immunohistochemistry, which detects a different alteration. Oral solid, room temperature.