Pralsetinib

(Gavreto®)

Pralsetinib

Latest News

loading GIF

Drug updated on 5/17/2024

Dosage FormCapsule (oral; 100 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).
  • Indicated for 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).

Summary
This AI-generated content is provided without warranty and may be inaccurate or outdated; it should be used only as a research starting point, with no liability accepted for reliance on it. Learn more.

  • Pralsetinib (Gavreto) is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer and advanced or metastatic RET fusion-positive thyroid cancer in adults and pediatric patients 12 years of age and older who require systemic therapy.
  • Three studies were reviewed to gather information about pralsetinib's safety, effectiveness, and comparison with other drugs like selpercatinib, including considerations for different populations and subgroups.
  • The studies reveal pralsetinib shows high efficacy in treating RET-altered tumors. Objective responses ranged from 60% to 89%, including complete and partial responses, and it was particularly effective among intracranial response subgroups, highlighting its potential advantages for specific populations.
  • Safety profiles indicate grade ≥3 adverse events reported in up to half of the patients treated with pralsetinib. Common side effects included hypertension, changes in ALT levels, QT prolongation, neutropenia, pneumonitis, and significant occurrences of anemia, but these must be considered against its demonstrated effectiveness.
  • Compared to selpercatinib, another drug used for similar conditions, both drugs are deemed effective while being generally well-tolerated by patients with RET-altered tumors according to one study review. However, direct comparisons between them remain controversial due to a lack of robust clinical evidence, according to some sources.
  • Despite promising results shown by pralsetinib, there remains a level of uncertainty around cost-effectiveness estimates leading to it not being recommended routinely within national health settings based on the current data available.