Brand Name

Gavreto

Generic Name
Pralsetinib
View Brand Information
FDA approval date: July 01, 2021
Classification: Kinase Inhibitor
Form: Capsule

What is Gavreto (Pralsetinib)?

GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection fusion-positive non-small cell lung cancer as detected by an FDA approved test .

Approved To Treat

Top Global Experts

Save this treatment for later
Sign Up
Not sure about your diagnosis?
Check Your Symptoms

Related Clinical Trials

Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial
Enrollment Status: Recruiting
Publish Date: December 17, 2025
Intervention Type: Drug
Study Phase: Phase 2

Summary: TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high...

NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer
NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer
Who is this study for: Patients with operable Stage IIA, IIB, IIIA, and select IIIB resectable and untreated non-small cell lung cancer tumors with selected molecular alterations
Enrollment Status: Recruiting
Publish Date: December 15, 2025
Intervention Type: Drug, Procedure
Study Drugs: Alectinib, Entrectinib, Vemurafenib, Cobimetinib, Chemotherapy, Pralsetinib
Study Phase: Phase 2

Summary: This trial will evaluate the efficacy and safety of various therapies in participants with Stage IB, IIA, IIB, IIIA, or selected IIIB resectable and untreated NSCLC tumors that meet protocol-specified biomarker criteria.

A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer
A Phase I-III, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients Selected According to Biomarker Status, With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer
Who is this study for: Patients with locally advanced, unresectable, stage III non-small cell lung cancer
Enrollment Status: Recruiting
Publish Date: December 04, 2025
Intervention Type: Drug
Study Drugs: Alectinib, Entrectinib, Pralsetinib, Durvalumab
Study Phase: Phase 3

Summary: This study will evaluate the efficacy and safety of multiple therapies in participants with locally advanced, unresectable, Stage III NSCLC with eligible biomarker status as determined by Version 8 of the American Joint Committee on Cancer/Union for International Cancer Control NSCLC staging system.

View All Clinical Trials

Related Latest Advances

RET Receptor Tyrosine Kinase Promotes Breast Cancer Metastasis to the Brain and RET Inhibitors Pralsetinib and Selpercatinib Suppress Breast Cancer Brain Metastases.
RET Receptor Tyrosine Kinase Promotes Breast Cancer Metastasis to the Brain and RET Inhibitors Pralsetinib and Selpercatinib Suppress Breast Cancer Brain Metastases.
Journal: bioRxiv : the preprint server for biology
Published: November 24, 2025
Corneal edema and epithelial defect during pralsetinib treatment.
Corneal edema and epithelial defect during pralsetinib treatment.
Journal: Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners
Published: September 29, 2025
Pathological complete response in RET-positive non-small cell lung cancer: a case report of pralsetinib-based "sandwich" therapy.
Pathological complete response in RET-positive non-small cell lung cancer: a case report of pralsetinib-based "sandwich" therapy.
Journal: Translational lung cancer research
Published: August 22, 2025
View All Latest Advances

Brand Information

Gavreto (Pralsetinib)
1DOSAGE FORMS AND STRENGTHS
Capsules: 100 mg, light blue, opaque, hard hydroxypropyl methylcellulose (HPMC) capsule printed with "BLU-667" on the capsule shell body and "100 mg" on the capsule shell cap.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Interstitial Lung Disease/Pneumonitis
  • Hypertension
  • Hepatotoxicity
  • Hemorrhagic Events
  • Tumor Lysis Syndrome
  • Risk of Impaired Wound Healing
  • Embryo-Fetal Toxicity
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population in the WARNINGS AND PRECAUTIONS reflect exposure to GAVRETO as a single agent at 400 mg orally once daily in 540 patients in ARROW
4DESCRIPTION
Pralsetinib is an oral receptor tyrosine kinase inhibitor. The chemical name for pralsetinib is (
Chemical Structure
The solubility of pralsetinib in aqueous media decreases over the range pH 1.99 to pH 7.64 from 0.880 mg/mL to < 0.001 mg/mL, indicating a decrease in solubility with increasing pH.
GAVRETO (pralsetinib) is supplied for oral use as immediate release hydroxypropyl methylcellulose (HPMC) hard capsules containing 100 mg pralsetinib. The capsules also contain inactive ingredients:
citric acid, hydroxypropyl methylcellulose (HPMC), magnesium stearate, microcrystalline cellulose (MCC), pregelatinized starch and sodium bicarbonate. The capsule shell consists of FD&C Blue #1 (Brilliant Blue FCF), hypromellose and titanium dioxide. The white printing ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution and titanium dioxide.
5HOW SUPPLIED/STORAGE AND HANDLING
GAVRETO (pralsetinib) 100 mg, light blue, opaque, immediate release, hydroxypropyl methylcellulose (HPMC) hard capsule printed with "BLU-667" on the capsule shell body and "100 mg" on the capsule shell cap are supplied as follows:
  • Bottles of 60 capsules (NDC 71332-006-60).
  • Bottles of 90 capsules (NDC 71332-006-90).
  • Bottles of 120 capsules (NDC 71332-006-12).
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
7PRINCIPAL DISPLAY PANEL - 60 Capsule - Carton
NDC 71332-006-60
GAVRETO®
(pralsetinib)
capsules
100 mg
For Oral Use
Rx only
60 Capsules
rigel
PRINCIPAL DISPLAY PANEL - 100 mg Capsule Carton - 60 Capsules
8PRINCIPAL DISPLAY PANEL - 90 Capsule - Carton
NDC 71332-006-90
GAVRETO®
(pralsetinib)
capsules
100 mg
For Oral Use
Rx only
90 Capsules
rigel
PRINCIPAL DISPLAY PANEL - 100 mg Capsule Carton - 90 Capsules