Skip to main content

gavreto

Generic: pralsetinib·Brand: GAVRETO, Gavreto

gavreto: sourced relationships with 2 companies · 3 clinical trials tracked · 2 FDA decisions.

gavreto evidence translation

What we can confirm

2 FDA records · 3 tracked trials

What it means

More than one company relationship is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about gavreto, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 0 study sponsors

Related indications

metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and advanced or metastatic RET fusion-positive thyroid cancerSolid TumorsThyroid Cancer

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (2)
CompanyDated record stage
Blueprint Medicines Corp (BPMC)
Reported 2020-12-01 · Current development: unknownSource
Approved
RIGEL PHARMACEUTICALS INC (RIGL)
licensee · Reported 2024-03-05 · Current development: unknownSource
metastatic RET fusion-positive non-small cell lung cancer (N…
Approved
Clinical Trial Registry Records (3)

A Multi-center, Open-label, Drug-drug Interaction Study to Evaluate the Effect of Pralsetinib (Gavreto) on the Pharmacokinetics of CYP3A4, CYP2C8, and CYP2C9 Substrates, and Hormones Estradiol/Norethisterone Acetate in Patients With Advanced or Metastatic Solid Tumors

NCT07704658Registry updated 2026-08-10·Phase 4·RIGL
Recruiting

Primary endpoint: Area Under the Plasma Concentration-Time Curve from zero to infinity (AUC0-inf)

Interventionalopen12 targetStarted 2026-03Completion 2027-082 sites · SpainRigel Pharmaceuticals

Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

NCT04589845Registry updated 2026-02-09·Phase 2
Recruiting

Primary endpoint: All Cohorts: Independent Review Committee (IRC)-assessed Objective Response Rate (ORR) Based on Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Interventionalopen920 targetStarted 2021-01Completion 2032-0950 sites · United StatesHoffmann-La Roche

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

NCT04302025Registry updated 2026-02-09·Phase 2
Recruiting

Primary endpoint: Tyrosine Kinase Inhibitor (TKI) Cohort: Proportion of Participants With Major Pathologic Response (MPR)

Interventionalopen99 targetStarted 2020-11Completion 2030-0538 sites · United StatesGenentech, Inc.
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE GAVRETO is a kinase inhibitor 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). ( 1.1 ) 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). This indication is appro(BPMC)FDA ↗
NDA214701Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after ApprovalOrphan DrugPriorityOralCapsule
Approval1 INDICATIONS AND USAGE GAVRETO is a kinase inhibitor 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). ( 1.1 ) 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). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ( 1.2 ) 1.1 Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer GAVRETO is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. 1.2 RET Fusion-Positive Thyroid Cancer GAVRETO is indicated for the 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). This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).(RIGL)FDA ↗
NDA213721Type 1 - New Molecular EntityOrphan DrugPriorityOralCapsule

Frequently asked questions

Which companies have sourced relationships with gavreto?

gavreto has dated SEC/FDA relationship records for Blueprint Medicines Corp, RIGEL PHARMACEUTICALS INC.

How many clinical trials involve gavreto?

BioSniper tracks 3 clinical trials involving gavreto.

What is gavreto's latest FDA decision?

The most recent tracked FDA decision for gavreto is Approval for 1 INDICATIONS AND USAGE GAVRETO is a kinase inhibitor 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). ( 1.1 ) 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). This indication is appro, dated December 1, 2020.