Prescription medicine
Alectinib Brand names: Alecensa
Alectinib (Alecensa) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the alectinib FDA label on DailyMed (effective August 21, 2026, Genentech, Inc.); the NDA 208434 record on Drugs@FDA; every alectinib label on DailyMed.
Highlights of the record
FDA label of August 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test.
Forms and strengths
- 150 mg
Capsule.
On the market
- Earliest approval on file
- December 11, 2015 Alecensa, Hoffmann-La Roche; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 24, 2035 Alecensa 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
- 7,249 through July 30, 2026
What is alectinib used for?
From the label: indications and usageALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test. ( 1.1 ) treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. […]
Conditions named in the indications of alectinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (ALECENSA), NDA208434 (Hoffmann-La Roche), as published by Genentech, Inc., effective August 21, 2026 (SPL set 42c49deb-713b-427a-9670-08af08adcffb), via openFDA; the full label on DailyMed
What does the patient leaflet for alectinib 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 ALECENSA?ALECENSA may cause serious side effects, including: Liver problems (hepatotoxicity). Liver problems are common with ALECENSA and can be severe. Tell your healthcare provider right away if you get any of the following signs and symptoms of liver problems: feeling tired feeling less hungry than usual yellowing of your skin or the whites of your eyes dark urine itchy skin nausea or vomiting pain on the right side of your stomach area bleeding or bruising more easily than normal Lung problems. ALECENSA may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you get any new or worsening symptoms of lung problems, including: trouble breathing shortness of breath cough fever Kidney problems. ALECENSA may cause severe kidney problems that can lead to death. Tell your healthcare provider right away if you get a change in the amount or color of your urine, or if you get new or worsening swelling in your legs or feet. Slow heartbeat (bradycardia). ALECENSA may cause very slow heartbeats that can be severe and life-threatening. Your healthcare provider will check your heart rate and blood pressure during treatment with ALECENSA. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint during treatment with ALECENSA. Tell your healthcare provider if you take any heart or blood pressure medicines. Severe muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with ALECENSA and can be severe. Treatment with ALECENSA can increase the level of an enzyme called creatine phosphokinase (CPK), which can be a sign of muscle damage. […]
From the patient leaflet: What should I avoid while taking ALECENSA?Avoid spending time in the sunlight during treatment with ALECENSA and for at least 7 days after stopping ALECENSA. Your skin may be sensitive to the sun (photosensitivity) and you may burn more easily and get severe sunburns. Use sun protecting measures, such as sunscreen and lip balm with an SPF 50 or greater to help protect against sunburn.
From the patient leaflet: How should I store ALECENSA?Do not store ALECENSA at temperatures above 86°F (30°C). Store ALECENSA capsules in the original container. Keep ALECENSA capsules dry and away from light. Keep ALECENSA and all medicines out of the reach of children.
Source: FDA drug label (ALECENSA), NDA208434 (Hoffmann-La Roche), as published by Genentech, Inc., effective August 21, 2026 (SPL set 42c49deb-713b-427a-9670-08af08adcffb), via openFDA; the full label on DailyMed
Is there a generic for alectinib (Alecensa)?
No generic alectinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Alecensa capsules: the compound patent runs to May 29, 2031, and the last listed entry to April 24, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2035 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 alectinib?
The FDA Adverse Event Reporting System holds 7,249 reports that list alectinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 935 are coded as a death and 1,280 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 rose sharply in 2024 (1,856, against a median of 589 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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 alectinib?
26 other medicines are given the same way (oral) and in the same FDA class as alectinib 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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to alectinib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Alectinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other