FDA Approval: Alectinib (Alecensa) for Lung Cancer

A drug aimed at one rearrangement

Alectinib, sold as Alecensa, was approved by the FDA in 2015. Its label carries an Initial U.S. Approval date of 2015. It treats one narrow slice of lung cancer: non-small cell lung cancer that is ALK positive.

ALK stands for anaplastic lymphoma kinase. In a small share of lung cancers, part of the ALK gene breaks off and joins another gene. The fused gene makes a protein that is stuck in the on position and keeps telling the cell to divide. Alectinib blocks that protein.

You cannot see this on a scan or under a microscope alone. It takes a molecular test. Our page on biomarker testing covers how those tests work.

The 2015 evidence

The first approval rested on two small single-arm trials in people whose ALK-positive lung cancer had already been treated with crizotinib, an earlier ALK inhibitor.

In the first trial, tumors shrank in 38 percent of patients, with median survival of 7.5 months. In the second, tumors shrank in 44 percent, with median survival of 11.2 months.

The finding that drew the most attention was in the brain. Among patients across both trials who had brain metastases, 61 percent had partial or complete shrinkage of those brain tumors, lasting a median of 9.1 months. Lung cancer that spreads to the brain has historically been hard to treat with drugs, because many do not cross into brain tissue well.

NCI also noted the side effect profile at the time. Patients appeared to tolerate alectinib better than crizotinib, with fewer needing dose reduction, interruption, or withdrawal. Reported side effects included fatigue, edema, constipation, and muscle pain.

What the label says now

Labels move. NCI currently lists alectinib as approved for adults with ALK-positive NSCLC in two settings: to prevent the cancer from coming back after surgery, and when the cancer has spread to other parts of the body.

That first use is newer. On April 18, 2024, the FDA approved alectinib as adjuvant treatment after tumor removal in ALK-positive NSCLC, detected by an FDA-approved test.

The evidence there was a randomized, open-label global trial called ALINA. It enrolled 257 patients with completely resected stage IB tumors of 4 centimeters or larger through stage IIIA, all with ALK rearrangements. They were randomized one to one to alectinib 600 mg twice daily or platinum-based chemotherapy after surgery. In the stage II to IIIA group, median disease-free survival was not reached with alectinib and was 44.4 months with chemotherapy. Trial patients all took the same strength. Yours comes from your own prescription.

The trial amount is recorded here for reference. What you take is decided by your own team and written on your prescription.

Not reached means that at the time of analysis, fewer than half the patients in that arm had a recurrence, so a median could not yet be calculated.

When to get checked

Lung cancer sometimes causes nothing and turns up on a chest X-ray done for another reason. When symptoms appear, NCI says to check with a doctor for:

• Chest discomfort or pain.
• A cough that does not go away or gets worse over time.
• Trouble breathing, or wheezing.
• Blood in sputum, the mucus coughed up from the lungs.
• Hoarseness.
• Loss of appetite, or weight loss for no known reason.
• Fatigue.
• Trouble swallowing.
• Swelling in the face, or in the veins of the neck.

Screening is separate and applies to tobacco risk, not ALK status. A yearly low-dose CT scan is recommended for adults aged 50 through 80 with a 20 pack-year smoking history who smoke now or quit within the past 15 years. ALK-positive lung cancer often occurs in people who never smoked, and no screening program covers them.

Finding the rearrangement

Diagnosis and staging usually happen together. Imaging maps the lung and the area around it. If lung cancer is suspected, a biopsy follows, because tissue is what settles the diagnosis.

Staging runs from occult, meaning cancer cells found in sputum or washings without a visible tumor, through stage 0, then stages I to IV. Stage reflects tumor size, spread within the chest, and spread beyond it.

The tissue is also tested for gene changes. NCI lists EGFR and ALK among the factors that affect prognosis and treatment options, alongside stage, cancer type, symptoms, and general health.

Where this sits in treatment

Treatment depends on stage and on whether surgery can remove the cancer. Early-stage disease is usually treated with surgery, sometimes followed by drug treatment. Stage III often involves chemotherapy and radiation. Stage IV is treated with drugs, chosen by the tumor's molecular profile.

For ALK-positive disease, an ALK inhibitor taken as a pill is standard rather than chemotherapy. Our page on targeted therapy explains the wider class.

NCI is direct about the ceiling here. For most people with non-small cell lung cancer, current treatments do not cure the cancer.

Group numbers, and their limits

These SEER numbers describe the whole population with lung and bronchus cancer. ALK-positive disease is a small subgroup within it, so these figures do not describe that subgroup specifically, and they do not describe any individual.

Five-year relative survival for lung and bronchus cancer is 29.5 percent for cases from 2016 to 2022. By stage it is 65.5 percent while confined to the lung, 38.2 percent once it reaches nearby lymph nodes, and 10.5 percent once it has spread further. Only 24 percent are found at the first stage, while 51 percent are already distant. An estimated 229,410 new cases and 124,990 deaths are projected for 2026, and median age at diagnosis is 71.

Our page on lung cancer covers the types and their differences.

What this approval cannot tell you

An approval for ALK-positive NSCLC says nothing about lung cancer without an ALK rearrangement. The ALINA result is a disease-free survival result, not an overall survival result, and disease-free survival counts recurrences rather than deaths. Whether alectinib fits a specific person depends on test results, stage, other medicines, and side effects.

Sources

• NCI, Alectinib — https://www.cancer.gov/about-cancer/treatment/drugs/alectinib
• NCI Cancer Currents, FDA approval of alectinib for NSCLC — https://www.cancer.gov/news-events/cancer-currents-blog/2016/fda-alectinib-nsclc
• FDA, alectinib as adjuvant treatment for ALK-positive NSCLC — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-alectinib-adjuvant-treatment-alk-positive-non-small-cell-lung-cancer
• DailyMed, ALECENSA (alectinib) label — https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=42c49deb-713b-427a-9670-08af08adcffb
• NCI PDQ, Non-Small Cell Lung Cancer Treatment (Patient Version) — https://www.cancer.gov/types/lung/patient/non-small-cell-lung-treatment-pdq
• SEER Cancer Stat Facts, Lung and Bronchus Cancer — https://seer.cancer.gov/statfacts/html/lungb.html
• USPSTF, Lung Cancer: Screening — https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening

How this article was prepared

An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.

The National Cancer Information Foundation publishes Cancer Explained. This page is for learning. It is not medical advice and does not suggest a test or treatment.

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