Selpercatinib

(Retevmo®)

Retevmo®

Drug updated on 5/17/2024

Dosage FormCapsule (oral; 40 mg, 80 mg); Tablets (oral; 40 mg, 80 mg, 120 mg, 160 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test.
  • Indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.
  • Indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
  • Indicated for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

Summary
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  • Selpercatinib (Retevmo) is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer, medullary thyroid cancer, and other solid tumors that have a rearranged during transfection gene fusion. It is also used in pediatric patients 12 years and older who require systemic therapy.
  • The information was derived from one systematic review/meta-analysis study which compared selpercatinib to pralsetinib, both FDA-approved RET-specific tyrosine kinase inhibitors.
  • Both drugs demonstrated high effectiveness in inducing tumor responses with objective response rates ranging between 60% to 89%. However, complete eradication of the tumor was less common, as shown by lower complete response rates between 0% and 11%.
  • Safety profiles showed grade three or higher adverse events reported in about a quarter to half of all treated patients. Common side effects included hypertension, altered liver enzymes (ALT changes), QT prolongation (a measure of altered heart rhythm), neutropenia (low white blood cell count), and pneumonitis (lung tissue inflammation).
  • There were no direct comparative data provided on safety and efficacy between selpercatinib and pralsetinib, but their overlapping ranges suggest similar effectiveness. Their safety profiles also appeared comparable based on listed side effects.
  • No specific details were given regarding population types or subgroup considerations such as age or gender. However, the indications for these drugs cover various RET-altered tumor types across different patient demographics, including adults and children aged over twelve, suggesting broad applicability.

Product Monograph / Prescribing Information

Document TitleYearSource
Retevmo (selpercatinib) Prescribing Information. 2024Lilly USA, LLC., Indianapolis, IN

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines