GAVRETO
Gavreto (pralsetinib) is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) that is rearranged during transfection (RET) fusion-positive. It is also indicated for adult and pediatric patients aged 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer. This therapy is reserved for thyroid cancer patients who require systemic therapy and are refractory to radioactive iodine treatment.
How GAVRETO Works
Pralsetinib is a kinase inhibitor that targets wild-type RET as well as various oncogenic RET fusions and mutations. These genetic alterations can hyperactivate downstream signaling pathways, which leads to the uncontrolled proliferation of cancer cells. By inhibiting these specific proteins, the drug demonstrates anti-tumor activity and reduces the tumorigenic potential in cancers harboring RET fusions or mutations.
Details
- Status
- Prescription
- First Approved
- 2020-09-04
- Routes
- ORAL
- Dosage Forms
- CAPSULE
GAVRETO Approval History
What GAVRETO Treats
2 indicationsGAVRETO is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Metastatic RET fusion-positive non-small cell lung cancer
- Advanced or metastatic RET fusion-positive thyroid cancer
GAVRETO Boxed Warning
SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ] . WARNING: SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS See full prescribing information for complete boxed warning. GAVR...
WARNING: SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ] . WARNING: SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS See full prescribing information for complete boxed warning. GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity. ( 2.3 , 5.1 )
GAVRETO Target & Pathway
ProTarget
A member of the JAK family involved in signaling for interferons and several interleukins. JAK1 inhibition is effective in rheumatoid arthritis, atopic dermatitis, and other inflammatory conditions by blocking multiple cytokine pathways.
GAVRETO Competitors
Pro6 other drugs also target FGFR1. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (FGFR1). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GAVRETO FDA Label Details
ProIndications & Usage
FDA Label (PDF)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). 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 b...
WARNING: SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on sev...
GAVRETO Patents & Exclusivity
Patents (5 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.