FDA approves Genentech's Alecensa (alectinib) for adjuvant treatment of ALK+ Non-Small Cell Lung Cancer (NSCLC) following tumor resection

On Apr. 18, 2024, FDA approved Genentech’s Alecensa (alectinib) for adjuvant treatment following tumor resection in ALK+ NSCLC.

Alectinib was first approved by the FDA in December 2015 for metastatic ALK+ NSCLC. 

This application used: 

• Project Orbis. For this review, FDA collaborated with the Australian Therapeutic Goods Administration, Health Canada, Israel’s Ministry of Health, Switzerland’s Swissmedic, and United Kingdom’s Medicines and Healthcare products Regulatory Agency. The application reviews are ongoing at the other regulatory agencies. Brazil's National Health Surveillance Agency (ANVISA) and Singapore’s Health Sciences Authority (HSA) will also be participating as Type C Project Orbis Partners. 
• Real-Time Oncology Review (RTOR)  
• Priority Review 
• Orphan Drug Designation 
• Assessment Aid 

FDA approved this application 1 month ahead of the FDA goal date. 

Link to FDA approval announcement 

Link to product label