# Pralsetinib

Source: https://onco.cc/drugs/pralsetinib/  
OnCo record `pralsetinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Pralsetinib is the second selective RET pill for lung cancer, less used than selpercatinib after a change of owner and label.

## Summary

Pralsetinib is a selective RET inhibitor that blocks the RET kinase in tumours driven by RET fusions or mutations while sparing most other kinases. It is used for RET-fusion metastatic non-small-cell lung cancer, where ARROW reported a response rate of about 72% in treatment-naive patients. It was approved in 2020, with full approval in 2023; the thyroid indications were withdrawn in the US in 2023 after Roche returned rights to Blueprint (now Rigel). It remains an option in RET-fusion NSCLC but is less used than selpercatinib, which has randomised phase 3 support and a broader label. For a newcomer, pralsetinib is the second of two RET-selective pills, effective but overshadowed by commercial and label changes rather than by weak efficacy.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-06
- Brand: Gavreto
- Modality: Small-molecule kinase inhibitor (RET)
- Mechanism: Selective RET inhibitor.
- Approvals: US 2020: RET-fusion metastatic NSCLC (full approval 2023); England (NICE) 2022: RET fusion-positive advanced non-small-cell lung cancer in patients who have not had a RET inhibitor: not recommended

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Pralsetinib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Pralsetinib
- NICE TA812: pralsetinib for treating RET fusion-positive advanced non-small-cell lung cancer (not recommended): https://www.nice.org.uk/guidance/ta812

## Connected records

- biomarkers: [RET fusion and RET mutation](https://onco.cc/biomarkers/ret-fusion/)
- cancers: [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Medullary thyroid cancer](https://onco.cc/cancers/medullary-thyroid-cancer/), [Multiple endocrine neoplasia syndromes (MEN1, MEN2, MEN4)](https://onco.cc/cancers/multiple-endocrine-neoplasia/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [RET fusion-positive non-small-cell lung cancer](https://onco.cc/cancers/ret-fusion-nsclc/), [Thyroid cancer](https://onco.cc/cancers/thyroid/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [RET](https://onco.cc/targets/ret/)
- drugs: [Oncomine Dx Target Test](https://onco.cc/drugs/oncomine-dx-target-test/), [Selpercatinib](https://onco.cc/drugs/selpercatinib/)
- companies: [Blueprint Medicines](https://onco.cc/companies/blueprint-medicines/), [CStone Pharmaceuticals](https://onco.cc/companies/cstone/), [Rigel Pharmaceuticals](https://onco.cc/companies/rigel-pharmaceuticals/)
- trials: [A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)](https://onco.cc/trials/nct04302025/), [ARROW (thyroid cohorts)](https://onco.cc/trials/arrow-thyroid/)
- terms: [Basket trial](https://onco.cc/terms/basket-trial/), [Lung cancer drugs in England: what NICE has recommended](https://onco.cc/terms/lung-uk-drug-access/), [Lung cancer: the failed and stopped programmes, and why](https://onco.cc/terms/lung-failed-programmes/)
- people: [Justin F. Gainor](https://onco.cc/people/justin-gainor/)
- key papers: [ARROW: pralsetinib for RET fusion-positive non-small-cell lung cancer](https://onco.cc/key-papers/paper-arrow-pralsetinib-gainor-lancet-oncol-2021/)
- pathways: [Non-small cell lung cancer (KEGG map)](https://onco.cc/pathways/nsclc-signalling/), [Thyroid cancer (KEGG map)](https://onco.cc/pathways/thyroid-cancer-signalling/)

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JSON: https://onco.cc/api/v1/entities/pralsetinib.json