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    Indications

    AUGTYRO® (repotrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

    AUGTYRO® (repotrectinib) is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:

    • have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion
    • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and
    • have progressed following treatment or have no satisfactory alternative therapy.

    This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial(s).

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ROS1+ NSCLC

AUGTYRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

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NTRK gene fusion+
solid tumors

AUGTYRO® (repotrectinib) is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:

  • have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion
  • are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and
  • have progressed following treatment or have no satisfactory alternative therapy.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial(s).

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