Prescription medicine
Entrectinib Brand names: Rozlytrek
Entrectinib (Rozlytrek) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the entrectinib FDA label on DailyMed (effective December 4, 2025, Genentech, Inc.); the NDA 212726 record on Drugs@FDA; every entrectinib label on DailyMed.
Highlights of the record
FDA label of December 4, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageROZLYTREK is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Forms and strengths
- 100 mg
- 200 mg
- 50 mg/201
Capsule; pellet.
On the market
- Earliest approval on file
- August 15, 2019 Rozlytrek, Genentech Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- July 18, 2038 Rozlytrek 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
- 1,653 through July 30, 2026
What is entrectinib used for?
From the label: indications and usageROZLYTREK is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ( 1.1 ) Adult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. […]
Conditions named in the indications of entrectinib's FDA labels, with every medicine labeled for each:
From other entrectinib labelsLung cancer: ROS1 -Positive Non-Small Cell Lung Cancer ROZLYTREK is indicated for the treatment of adult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
Source: FDA drug label (Rozlytrek), Genentech, Inc., effective December 4, 2025 (SPL set c7c71b0c-2549-4495-86b6-c2807fa54908), via openFDA; the full label on DailyMed
What does the patient leaflet for entrectinib 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 ROZLYTREK?ROZLYTREK may cause serious side effects, including: Congestive heart failure. ROZLYTREK may cause congestive heart failure or make the congestive heart failure that you already have worse. Your healthcare provider will do tests before your treatment and may do tests during your treatment with ROZLYTREK to check your heart function. Tell your healthcare provider right away if you have any of the following signs and symptoms of congestive heart failure: persistent coughing or wheezing trouble breathing when lying down sudden weight gain increasing shortness of breath tiredness, weakness, or fatigue swelling in ankles, feet, or legs Central nervous system (CNS) effects. ROZLYTREK may cause dizziness, changes in your mood, or may affect how you think and cause confusion, hallucinations, and problems with concentration, attention, memory, speaking, understanding what your hear or read, and sleep. Tell your healthcare provider right away if you have any of these symptoms. Bone fractures. ROZLYTREK may increase your risk for bone fractures. Bone fractures may happen with or without a fall or other injury. Tell your healthcare provider if you develop pain, changes in movement, or bone abnormalities. Liver problems (hepatotoxicity). Your healthcare provider will do blood tests to check your liver function during treatment with ROZLYTREK. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems: loss of appetite nausea or vomiting pain in your upper right stomach area yellowing of your skin or the white part of your eyes dark urine Increased uric acid level in your blood (hyperuricemia). ROZLYTREK may cause too much uric acid in your blood. […]
From the patient leaflet: What should I avoid while taking ROZLYTREK?You should not drink grapefruit juice or eat grapefruit during your treatment with ROZLYTREK. It may increase the amount of entrectinib in your blood to a harmful level and increase your chance of getting side effects. Do not drive or operate heavy machinery until you know how ROZLYTREK affects you. If you experience dizziness, fainting, tiredness, blurred vision, memory loss, changes in mental status, confusion, or hallucinations, do not drive or operate heavy machines until your symptoms resolve.
From the patient leaflet: How should I store ROZLYTREK?ROZLYTREK capsules Store ROZLYTREK at room temperature between 68°F to 77°F (20°C to 25°C). Store ROZLYTREK capsules in the original container and keep the bottle tightly closed to protect from moisture. ROZLYTREK oral pellets Store ROZLYTREK oral pellets at room temperature between 68°F to 77°F (20°C to 25°C). Store ROZLYTREK oral pellets in the original container to protect from moisture. Keep ROZLYTREK and all medicines out of the reach of children.
Source: FDA drug label (Rozlytrek), Genentech, Inc., effective December 4, 2025 (SPL set c7c71b0c-2549-4495-86b6-c2807fa54908), via openFDA; the full label on DailyMed
Is there a generic for entrectinib (Rozlytrek)?
No generic entrectinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 14 patents for Rozlytrek capsules: the compound patent runs to May 18, 2037, and the last listed entry to July 18, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the entrectinib label say about other medicines?
The entrectinib label names no other medicine on this site. The labels of 1 other medicine name entrectinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name entrectinib
Source: FDA drug label (Rozlytrek), Genentech, Inc., effective December 4, 2025 (SPL set c7c71b0c-2549-4495-86b6-c2807fa54908), via openFDA; the full label on DailyMed
What do FAERS reports show for entrectinib?
The FDA Adverse Event Reporting System holds 1,653 reports that list entrectinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 271 are coded as a death and 350 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 entrectinib?
26 other medicines are given the same way (oral) and in the same FDA class as entrectinib 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 |
| Dacomitinib | Lung cancer | none listed | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as entrectinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to entrectinib
- 26 medicines for the same use
- Entrectinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other