FDA Approves First ALK Inhibitor for Adjuvant Therapy in Early-Stage NSCLC


Alectinib was approved for the treatment of patients with ALK-positive non-small cell lung cancer after surgical resection.

FDA Approves First ALK Inhibitor for Adjuvant Therapy in Early-Stage NSCLC

FDA Approves First ALK Inhibitor for Adjuvant Therapy in Early-Stage NSCLC

The FDA approved alectinib (Alecensa) as adjuvant therapy after tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) with tumors at least 4 cm or node positive.

This marks the first ALK inhibitor for patients with ALK-positive early-stage NSCLC whose tumor was surgically removed, according to a press release from Genentech, the manufacturer of the drug.

The FDA approval was based on findings from the phase 3 ALINA study (NCT03456076), which demonstrated that patients treated with alectinib had a reduced risk for disease recurrence by 76% (HR = 0.24; 95% CI, 0.13-0.43; P < .0001) vs platinum-based chemotherapy. Of note, patients in this trial had a completely resected IB (tumor of at least 4 cm) to IIIA ALK-positive NSCLC.

An exploratory analysis performed in this study also indicated improvements in central nervous system-disease-free survival in patients treated with alectinib (HR = 0.22; 95% CI, 0.08-0.58).

“With an unprecedented 76% reduction in the risk of disease recurrence or death vs chemotherapy, Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” Levi Garraway, MD, Ph.D., chief medical officer and head of Global Product Development for Genentech, said in the release.

The safety and tolerability of the drug, as demonstrated in the ALINA study, were similar and consistent to those observed in previous trials, with no unexpected safety findings, according to the release.

The most common adverse reactions, occurring in at least 20% of patients treated with alectinib, included constipation, hepatotoxicity, myalgia, rash, fatigue, COVID-19, and cough, as noted in the release from the FDA.

The agency recommends a 600-mg dose of alectinib given orally twice per day with food for 2 years or until unacceptable toxicity or disease recurrence.

“The approval of Alecensa marks a pivotal moment for people newly diagnosed with early-stage ALK-positive lung cancer who, until now, were not able to receive ALK-specific therapy,” Ken Culver, Director of Research and Clinical Affairs at ALK Positive, Inc., said in the release. “These patients, who are typically diagnosed at a younger age, often face recurrence and have a higher risk of developing brain metastases than those with other types of NSCLC. Now, with this significant advance, it is more important than ever that all people diagnosed with early-stage lung cancer undergo testing for ALK and other recommended biomarkers to receive the treatment most appropriate for them.”


FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer. News release. Genentech. April 18, 2024. Accessed April 18, 2024. https://www.gene.com/media/press-releases/15023/2024-04-18/fda-approves-genentechs-alecensa-as-firs

FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer. News release. FDA. April 18, 2024. Accessed April 18, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-alectinib-adjuvant-treatment-alk-positive-non-small-cell-lung-cancer

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