FDA approved Alecensa (alectinib) for Adjuvant Treatment of ALK-Positive NSCLCFDA approved Alecensa for early lung cancer after surgery to reduce recurrence risk.

FDA From the archive Source published December 11, 2015 Summary added June 16, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider Alecensa for adjuvant treatment of ALK-positive NSCLC after resection in patients with tumors ≥4 cm or node positive.

The FDA has approved Alecensa (alectinib) for the adjuvant treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following tumor resection, specifically for those with tumors ≥4 cm or node positive. This marks a new indication for the kinase inhibitor, which was previously approved only for metastatic ALK-positive NSCLC. The approval allows for earlier intervention in the disease course, potentially reducing the risk of recurrence after surgery. Clinicians should select patients based on ALK positivity detected by an FDA-approved test. The recommended dose is 600 mg orally twice daily with food, continued for a total of 2 years or until disease recurrence or unacceptable toxicity.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Alecensa is a kinase inhibitor that targets anaplastic lymphoma kinase (ALK).

Indication & Patient Population

Alecensa is indicated for adjuvant treatment in adult patients following tumor resection of ALK-positive NSCLC (tumors ≥4 cm or node positive) as detected by an FDA-approved test. It is also indicated for treatment of adult patients with ALK-positive metastatic NSCLC.

Dosing & Administration

The recommended dosage is 600 mg orally twice daily with food. For adjuvant treatment, duration is 2 years or until disease recurrence or unacceptable toxicity. For metastatic NSCLC, continue until disease progression or unacceptable toxicity. Swallow capsules whole. If a dose is missed or vomiting occurs, take the next dose at the scheduled time. In patients with severe hepatic impairment (Child-Pugh C), reduce dose to 450 mg orally twice daily. Dose reductions for adverse reactions: first reduction to 450 mg twice daily, second to 300 mg twice daily; discontinue if unable to tolerate 300 mg twice daily.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Dose modifications are required for adverse reactions including ALT/AST elevations, bilirubin elevations, ILD/pneumonitis, renal impairment, symptomatic bradycardia, CPK elevations, and hemolytic anemia. Specific criteria for withholding, reducing, or permanently discontinuing Alecensa are provided in the label.

Place in Therapy

Alecensa is a treatment option for adjuvant therapy in resected ALK-positive NSCLC with high-risk features (tumor ≥4 cm or node positive) and for metastatic ALK-positive NSCLC.

The FDA has approved Alecensa (alectinib) for a new use: treating certain patients with early stage lung cancer after surgery. Alecensa is a targeted therapy for people whose lung cancer cells have a specific change called an ALK mutation. This approval is for patients with ALK-positive non-small cell lung cancer (NSCLC) whose tumor was at least 4 centimeters or had spread to nearby lymph nodes. The goal is to lower the chance of the cancer coming back after the tumor is removed.

Previously, Alecensa was only approved for lung cancer that had already spread to other parts of the body (metastatic). Now, it can be used earlier, right after surgery. The recommended dose is 600 mg taken by mouth twice a day with food, for up to 2 years or until the cancer returns or side effects become too severe.

This approval is based on a study that showed Alecensa helped people stay cancer-free longer after surgery compared to chemotherapy. However, it is not a cure, and not everyone will benefit. Patients must have their tumor tested for the ALK mutation using an FDA-approved test to see if they are eligible.

If you or a loved one has lung cancer and is considering this treatment, talk to your doctor. They can help you understand if Alecensa is right for your specific situation and discuss the possible benefits and risks.

What this means for you:

Alecensa is now approved for early ALK-positive lung cancer after surgery to help prevent recurrence.

Study Details

Study typeFda approval

PublishedDec 2015

View Original Abstract ↓

1 INDICATIONS AND USAGE ALECENSA 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. ( 1.2 ) 1.1 Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer (NSCLC) ALECENSA is indicated as 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 [see Dosage & Administration (2.1) ]. 1.2 Treatment of Metastatic ALK-Positive NSCLC ALECENSA is indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test [see Dosage & Administration (2.1) ] .

FDA approved Alecensa (alectinib) for Adjuvant Treatment of ALK-Positive NSCLCFDA approved Alecensa for early lung cancer after surgery to reduce recurrence risk.

Study Details

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FDA approved Alecensa (alectinib) for Adjuvant Treatment of ALK-Positive NSCLCFDA approved Alecensa for early lung cancer after surgery to reduce recurrence risk.

Study Details

Experimental agents show response rates up to 70% in relapsed or refractory diffuse large B-cell lymphoma

New cancer therapies double response rates for tough lymphoma

Clinical research that matters. Delivered to your inbox.

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