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FDA Clears First-Line Lung Cancer Drug

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March 02, 2026

Prelims: Current events of national and international importance | Health

Why in News?

Recently, the U.S. Food and Drug Administration (FDA) approved zongertinib (Hernexeos) of Boehringer Ingelheim as a first-line treatment for a rare form of lung cancer.

Zongertinib

  • The drug Zongertinib is marketed as Hernexeos.
  • Type – The drug is a Tyrosine kinase inhibitor (TKI).

Tyrosine kinase is a protein in the body that helps control how cells grow and function by sending signals inside the cell.

  • Tyrosine kinase inhibitors (TKIs) are a kind of targeted therapy.
  • They work by blocking tyrosine kinase enzymes, stopping cancer cells from growing and dividing. 
  • Target – For adults with advanced non-squamous non-small cell lung cancer (NSCLC) having HER2 (ERBB2) tyrosine kinase domain mutations.
  • Approval Status – Earlier approved for the patient whose cancer progressed despite prior treatment.
  • Now approved as first-line treatment for previously untreated patients.
  • Clinical result – Around 76% of untreated patients showed substantial tumour reduction, compared to current standard of care which achieved 30–45%.
  • Benefits – It may be easier to take, have fewer side effects, and work better than current treatments.

Non-Small Cell Lung Cancer (NSCLC)

  • Disease – Most common form of lung cancer, typically growing and spreading more slowly than small cell lung cancer.
  • TypeAdenocarcinoma – Most common type that usually starts in mucus-producing gland cells, often in the outer parts of the lung.
  • Squamous cell carcinoma – Starts in the central airways within the flat cells lining the airways.
  • Large cell carcinoma – A less common, fast-growing type that can appear anywhere.
  • SymptomsPersistent cough, coughing up blood, chest pain, breathlessness, hoarseness, weight loss, and sometimes bone pain or neurological problems in advanced stages.
  • CauseMainly due to tobacco smoking.
  • Also linked exposure to asbestos, radon, arsenic, chromium, nickel, ionising radiation, and air pollution.
  • Higher risk in pulmonary fibrosis and HIV patients.
  • Stages In early stages (I–III), the cancer is mainly limited to the lung or nearby areas and may still be cured with treatment.
  • In Stage IV, the cancer has spread to distant organs like the brain, bones, or liver, making it harder to cure.
  • Treatment
    • Surgery for the removal of the tumour
    • Chemotherapy with anti-cancer drugs
    • Radiation therapy involves high-energy rays to kill cancer cells.
    • Targeted therapy with drugs acting on specific gene mutations
    • Immunotherapy (boosts the body’s immune system to fight cancer), and combination therapy, depending on stage and patient condition.

References

  1. TH | FDA Clears First-Line Lung Cancer Drug
  2. FDA | Zongertinib
  3. NCBI | Non-Small Cell Lung Cancer Treatment
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