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AstraZeneca Seeks US Approval for HUTCHMED Lung Cancer Combination
AstraZeneca asked US regulators to approve a combination of two cancer medicines.
The medicines are ORPATHYS and TAGRISSO.
They are meant for people with advanced lung cancer.
These patients previously received treatment aimed at EGFR, a protein that helps cells grow.
Their cancer later continued or returned despite that treatment.
HUTCHMED said the combination kept the cancer from worsening for longer than chemotherapy.
It also said patients lived longer overall compared with chemotherapy.
ORPATHYS has already been approved in China based on a different Phase III study.
AstraZeneca submitted a US Food and Drug Administration application for the ORPATHYS-TAGRISSO combination.
The treatment is intended for patients with advanced lung cancer whose disease progressed after prior EGFR-targeted treatment.
HUTCHMED said the combination extended progression-free survival and improved overall survival versus chemotherapy.
ORPATHYS is jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.
ORPATHYS has already been approved in China based on results from a separate Phase III study.
- Who
- AstraZeneca and HUTCHMED are developing the treatment; AstraZeneca submitted the application.
- What
- A US approval application was filed for the ORPATHYS-TAGRISSO combination to treat advanced lung cancer.
- Where
- The application was submitted to the United States Food and Drug Administration; ORPATHYS is already approved in China.
- When
- The application was reported on September 29, 2026.
- Why
- The treatment is intended for patients whose cancer progressed after prior EGFR-targeted treatment.
Key facts
- Treatment
- ORPATHYS-TAGRISSO combination
- Regulatory action
- AstraZeneca applied to the United States Food and Drug Administration
- Disease
- Advanced lung cancer
- Target population
- Patients whose cancer progressed after prior EGFR-targeted treatment
- Reported benefit
- Extended progression-free survival and improved overall survival compared with chemotherapy
- Existing approval
- ORPATHYS is approved in China
- Development and commercialization
- ORPATHYS is jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca
Sources
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