Retevmo (selpercatinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

Loxo Oncology Inc. Retevmo (selpercatinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00078253.PDF. Revised January 2025. Accessed June 2025.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
RETEVMO (selpercatinib) is indicated as monotherapy for the treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC) in adult patients. 1
RETEVMO (selpercatinib) is indicated as monotherapy for the treatment of RET-mutant medullary thyroid cancer (MTC) in adult and pediatric patients 12 years of age and older with unresectable advanced or metastatic disease. 1
RETEVMO (selpercatinib) is indicated as monotherapy for the treatment of RET fusion-positive differentiated thyroid carcinoma in adult patients with advanced or metastatic disease (not amenable to surgery or radioactive iodine therapy) following prior treatment with sorafenib and/or lenvatinib. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) v::RET Non-Small Cell Lung Cancer Selpercatinib
Sensitivity (+) RET oncogenic variants Medullary Thyroid Cancer Selpercatinib
Sensitivity (+) v::RET Papillary Thyroid Cancer Selpercatinib