Prescription medicine
Pralsetinib Brand names: Gavreto
Pralsetinib (Gavreto) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the pralsetinib FDA label on DailyMed (effective December 30, 2025, Rigel Pharmaceuticals, Inc.); the NDA 213721 record on Drugs@FDA; every pralsetinib label on DailyMed.
Highlights of the record
FDA label of December 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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.
Used for
From the label: indications and usageGAVRETO 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).
Forms and strengths
- 100 mg
Capsule.
On the market
- Earliest approval on file
- September 4, 2020 Gavreto, Rigel Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 19, 2043 Gavreto capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,788 through July 30, 2026
What is pralsetinib used for?
From the label: indications and usageGAVRETO 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). […]
Conditions named in the indications of pralsetinib's FDA labels, with every medicine labeled for each:
From other pralsetinib labelsLung cancer: 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.
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Gavreto), Rigel Pharmaceuticals, Inc., effective December 30, 2025 (SPL set 16edd46e-28b8-f06d-e063-6394a90ae31b), via openFDA; the full label on DailyMed
What does the patient leaflet for pralsetinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about GAVRETO?GAVRETO may cause serious side effects, including: Serious infections. GAVRETO may increase your risk for serious infections, including infections caused by bacteria, fungi, or viruses, or infections that can happen when your immune system is weak (opportunistic infections). These serious infections can lead to hospitalization or death. Tell your healthcare provider right away if you get symptoms of an infection, including: chills body aches fever confusion nausea vomiting stomach pain weakness diarrhea cough or shortness of breath burning or pain when you urinate skin rash See "What are the possible side effects of GAVRETO?" for more information about side effects.
From the patient leaflet: How should I store GAVRETO?Store GAVRETO at room temperature between 68°F to 77°F (20°C to 25°C). Protect GAVRETO from moisture. Keep GAVRETO and all medicines out of the reach of children.
Source: FDA drug label (Gavreto), Rigel Pharmaceuticals, Inc., effective December 30, 2025 (SPL set 16edd46e-28b8-f06d-e063-6394a90ae31b), via openFDA; the full label on DailyMed
Is there a generic for pralsetinib (Gavreto)?
No generic pralsetinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Gavreto capsules: the compound patent runs to July 7, 2042, and the last listed entry to April 19, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2043 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for pralsetinib?
The FDA Adverse Event Reporting System holds 1,788 reports that list pralsetinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 252 are coded as a death and 520 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as pralsetinib?
26 other medicines are given the same way (oral) and in the same FDA class as pralsetinib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Lorlatinib | Lung cancer | none listed | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as pralsetinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to pralsetinib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Pralsetinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other