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Alecensa Approved as First and Only ALK Inhibitor for Non-Small Cell Lung Cancer

Drug approved for patients with ALK-positive, early-stage cancer who undergo surgery to remove their tumor

By Lori Solomon HealthDay Reporter

MONDAY, April 22, 2024 (HealthDay News) — The U.S. Food and Drug Administration has approved Alecensa (alectinib) as adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

The approval was based on positive results from the phase 3 ALINA study that showed Alecensa reduced the risk for disease recurrence or death (hazard ratio, 0.24) versus platinum-based chemotherapy in patients with completely resected IB (tumor ≥4 cm) to IIIA ALK-positive NSCLC. An exploratory analysis showed an improvement of central nervous system disease-free survival (hazard ratio, 0.22). No unexpected safety findings emerged.

“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, from ALK Positive Inc., said in a statement. “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.”

Approval of Alecensa was granted to Genentech.

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