Intelligence Feed event · Policy · 2026-09-29

    AstraZeneca Submits US NDA for Savolitinib and Tagrisso in MET-Driven Lung Cancer

    Question

    AstraZeneca Submits US NDA for Savolitinib and Tagrisso in MET-Driven Lung Cancer

    Direct answer

    AstraZeneca submitted a New Drug Application to the US Food and Drug Administration for the combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib). The submission focuses on patients diagnosed with MET-driven, EGFR-mutated non-small cell lung cancer who have experienced disease progression following EGFR-TKI therapy. The regulatory filing represents an advance for HUTCHMED's targeted oncology pipeline in the United States and provides AstraZeneca an established combination pathway to treat secondary resistance mechanisms in its oncology franchise.

    Original publisher
    Market Ontology
    Evidence through
    2026-09-29
    Published
    2026-10-20
    Revision
    1 · 2026-10-20

    Cite as: Market Ontology, “AstraZeneca Submits US NDA for Savolitinib and Tagrisso in MET-Driven Lung Cancer”, revision 1, evidence through 2026-09-29. https://marketontology.com/market-events/2026-09-29/astrazeneca-submits-us-nda-for-savolitinib-and-tagrisso-in-met-driven-lung-cance-047917

    POLICY
    AstraZeneca Submits US NDA for Savolitinib and Tagrisso in MET-Driven Lung Cancer
    AstraZeneca submitted a New Drug Application to the US Food and Drug Administration for the combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib). The submission focuses on patients diagnosed with MET-driven, EGFR-mutated non-small cell lung cancer who have experienced disease progression following EGFR-TKI therapy. The regulatory filing represents an advance for HUTCHMED's targeted oncology pipeline in the United States and provides AstraZeneca an established combination pathway to treat secondary resistance mechanisms in its oncology franchise.
    HCMAZN
    Impact
    68
    SEP 29
    SIG
    92%
    HCMAZN
    AstraZeneca Submits US NDA for Savolitinib and Tagrisso in MET-Driven Lung Cancer
    AstraZeneca submitted a New Drug Application to the US Food and Drug Administration for the combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib). The submission focuses on patients diagnosed with MET-driven, EGFR-mutated non-small cell lung cancer who have experienced disease progression following EGFR-TKI therapy. The regulatory filing represents an advance for HUTCHMED's targeted oncology pipeline in the United States and provides AstraZeneca an established combination pathway to treat secondary resistance mechanisms in its oncology franchise.
    → FDA regulatory review acceptance creates milestone potential for HUTCHMED and extends AstraZeneca's TAGRISSO franchise lifecycle into MET resistance indications.
    Impact
    AstraZeneca submitted a New Drug Application to the US Food and Drug Administration for the combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib). The submission focuses on patients diagnosed with MET-driven, EGFR-mutated non-small cell lung cancer who have experienced disease progression following EGFR-TKI therapy. The regulatory filing represents an advance for HUTCHMED's targeted oncology pipeline in the United States and provides AstraZeneca an established combination pathway to treat secondary resistance mechanisms in its oncology franchise.
    Affected
    HCMAZN
    Transmission
    FDA regulatory review acceptance creates milestone potential for HUTCHMED and extends AstraZeneca's TAGRISSO franchise lifecycle into MET resistance indications.

    How this development reaches the affected companies

    AssetExposure and channelDirectionEvidence
    HCMregulatory milestone progress toward US commercial launch of savolitinibUp1-4wAstraZeneca submitted US NDA for savolitinib combined with osimertinib
    AZNexpansion of Tagrisso indication into secondary MET resistance mutationsUp1-3mUS NDA submitted for Tagrisso plus savolitinib combination

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    What happened next

    AssetCallBase close+1 day+5 days+20 days
    HCMUpagreed14.15 2026-09-29+3.39%PendingPending

    Closing prices from stored daily bars; returns measured from the last close on or before the event date. Not a recommendation.

    No verifiable public source recorded for this card.

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