INDICATIONS AND USAGE（适应症）

Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

RETEVMO™ is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).

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 confirmatory trial(s).

RET-Mutant Medullary Thyroid Cancer

RETEVMO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic 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 confirmatory trial(s).

RET Fusion-Positive Thyroid Cancer

RETEVMO is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

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 confirmatory trial(s).

DOSAGE（服用剂量）

The recommended dosage of RETEVMO based on body weight is:

Less than 50 kg: 120 mg

50 kg or greater: 160 mg

Take RETEVMO orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity.

Swallow the capsules whole. Do not crush or chew the capsules.

Do not take a missed dose unless it is more than 6 hours until next scheduled dose.

If vomiting occurs after RETEVMO administration, do not take an additional dose and continue to the next scheduled time for the next dose.

ADVERSE REACTIONS（不良反应）

Hepatotoxicity

Hypertension

QT Interval Prolongation

Hemorrhagic Events

Hypersensitivity

Tumor Lysis Syndrome

Risk of Impaired Wound Healing

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/7fa848ba-a59c-4144-9f52-64d090f4d828/spl-doc?hl=Selpercatinib

Retevmoinformation