Story perspectives

FDA Approves Hernexeos for Advanced Lung Cancer Treatment

2/27/2026

Summary

Story summary

The U.S. FDA approved Boehringer Ingelheim's zongertinib, sold as Hernexeos, for first-line treatment of advanced HER2-positive non-small cell lung cancer (NSCLC).
It is the second drug approved under the FDA's expedited review program, potentially doubling the market.
A study shows a 76% response rate in untreated patients.
Boehringer aims to compete with Enhertu, which is given intravenously.
The decision underscores efforts to speed treatment access, though legal challenges remain.

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Story summary

The U.S. FDA approved Boehringer Ingelheim's zongertinib, sold as Hernexeos, for first-line treatment of advanced HER2-positive non-small cell lung cancer (NSCLC).
It is the second drug approved under the FDA's expedited review program, potentially doubling the market.
A study shows a 76% response rate in untreated patients.
Boehringer aims to compete with Enhertu, which is given intravenously.
The decision underscores efforts to speed treatment access, though legal challenges remain.