Alecensa Approved as First and Only ALK Inhibitor for Non-Small Cell Lung Cancer
By Lori Solomon HealthDay Reporter
MONDAY, April 22, 2024 -- 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.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted April 2024
Read this next
Perioperative Nivolumab Tops Chemo for Survival in Resectable Lung Cancer
FRIDAY, May 17, 2024 -- For patients with resectable non-small cell lung cancer (NSCLC), perioperative treatment with nivolumab results in significantly longer event-free...
AACR Delivers Report on Disparities in Cancer Progress
WEDNESDAY, May 15, 2024 -- In its biennial Cancer Disparities Progress Report published today, the American Association for Cancer Research presents the latest statistics on...
Adjuvant Alectinib Improves Disease-Free Survival in Lung Cancer
FRIDAY, April 12, 2024 -- Adjuvant alectinib improves disease-free survival compared with platinum-based chemotherapy among patients with resected ALK-positive non-small cell lung...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.