Gavreto

(Pralsetinib)

ApprovedSmall molecule

Gavreto is a small molecule that works as a RET Inhibitor.[2] It is being used across 2 indications, with its most advanced program in Approved.[1]

Gavreto is one of 72 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Non-Small Cell Lung CancerActive, not recruiting

Thyroid CancerActive, not recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Thyroid CancerApproved

Active, not recruiting

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Gavreto

RRigel Pharmaceuticals

Approved

3 2

Yervoy

Bristol-Myers Squibb

Preclinical

31 3

Gemzar

GGynecologic Oncology Group

Preclinical

72 4

PORTRAZZA

Eli Lilly

Preclinical

8 5

Lenvima

Eisai

Preclinical

6 6

Imjudo

AstraZeneca

Preclinical

5 7

Ofev

Boehringer Ingelheim

Preclinical

7 8

Immunotherapy

Bristol-Myers Squibb

Preclinical

12 9

Remeron

OOrganon and Co

Preclinical

1 10

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Recruiting

Solid Tumor

NCT05525858

Q4 2028

N/ANot yet recruiting

Real-World Study

NCT07418879

Post-ApprovalNot yet recruiting

Thyroid Cancer

NCT07010393

Q4 2029

Phase 2Recruiting

Unresectable

NCT06563999

Q2 2030

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT04302025

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer3 trials

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

Terminated· Roche logo

Roche·Phase 3·NCT04222972·223 enrolled

Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors

Completed· Roche logo

Roche·Phase 1/2·NCT03037385·590 enrolled

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

Recruiting· Roche logo

Roche·Phase 2·NCT04302025·99 enrolled

Thyroid Cancer3 trials

Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer

Recruiting·WWest China Hospital·Phase 2·NCT06482086·75 enrolled

A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).

Withdrawn· Roche logo

Roche·Phase 3·NCT04760288

Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study

Not yet recruiting·FFujian Medical University·Phase 4·NCT07010393·335 enrolled

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Real-world Study1 trial

A Real-world Study of Pralsetinib Combined With Leucogen in the Treatment of RET Fusion-positive NSCLC

Not yet recruiting·FFudan University·N/A·NCT07418879·25 enrolled

Unresectable1 trial

Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

Recruiting·SSun Yat-sen University·Phase 2·NCT06563999·120 enrolled

4 more indications

Metastatic NSCLC1 trial

Pre-Approval Access Program (PAAP) for Pralsetinib (BLU-667) in Patients With Unresectable or Metastatic NSCLC or MTC

Approved for marketing·BBlueprint Medicines··NCT04204928

Oncology1 trial

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

Recruiting· Roche logo

Roche·Phase 2·NCT04589845·920 enrolled

Advanced Solid Tumors1 trial

A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

Completed· Roche logo

Roche·Phase 2·NCT04632992·252 enrolled

Solid Tumor1 trial

KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II

Recruiting·SSeoul National University Bundang Hospital··NCT05525858·1,000 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 4, 2020

GAVRETO

NDA NDA213721

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Pralsetinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pralsetinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pralsetinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213721). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Gavreto. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Rigel Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: RET Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: RRigel Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Nov 1, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10030005Nov 1, 2036

11273160Apr 3, 2039

12539303Apr 3, 2039

11872192Apr 3, 2039

11963958Apr 3, 2039

1 more patents

12448366Jul 7, 2042

Gavreto

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2028

Q4 2029

Q2 2030

Trials by Indication[1]

Non-Small Cell Lung Cancer3 trials

Thyroid Cancer3 trials

Immunotherapy1 trial

Real-world Study1 trial

Unresectable1 trial

Metastatic NSCLC1 trial

Oncology1 trial

Advanced Solid Tumors1 trial

Solid Tumor1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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