FDA Approves Alecensa for ALK-Positive NSCLC

The Food and Drug Administration (FDA) has approved Alecensa (alectinib) for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) that is 4 cm or larger and has been surgically removed, according to Genentech, the manufacturer of the targeted agent.

Alecensa, according to Genentech, is the first and only ALK inhibitor approved for patients with early-stage NSCLC that has undergone surgical resection.

“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,” said Ken Culver, Director of Research and Clinical Affairs at ALK Positive, Inc. “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.”

The approval is based on findings from the phase 3 ALINA study that involved 257 patients who were randomly assigned to receive either Alecensa or platinum-based chemotherapy. Findings showed that Alecensa reduced the risk of disease reduction or death by 76% compared to platinum-based chemotherapy for patients with completely resected stage 1B to 3A ALK-positive NSCLC.

In patients with stage 2-3A disease, median disease-free survival was not reached, meaning that not enough patients experienced disease progression or complications to calculate an average in the Alecensa group, and 44.4 months in the chemotherapy group. In the overall study population, disease-free survival was also not reached and was 41.3 months in the Alecensa and chemotherapy groups, respectively.

READ MORE:Alecensa Reduces Recurrence, Mortality Risk in Lung Cancer Subset

An exploratory analysis of the trial also showed an improvement in central nervous system disease-free survival.

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

The most common side effects that occurred in 20% or more of patients included hepatotoxicity, constipation, myalgia, COVID-19, fatigue, rash and cough.

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