FDA Approval Announcement
South San Francisco, CA -- April 18, 2024 -- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test. Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor.
Company Statement on Clinical Impact
“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 Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “At Genentech, our goal is to give patients the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread. This approval brings us one step closer to achieving that mission.”
Patient Advocacy Perspective
“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.”
Basis for Approval: Phase III ALINA Study
The approval is based on positive results from the Phase III ALINA study that demonstrated Alecensa reduced the risk of disease recurrence or death by 76% (hazard ratio [HR]=0.24, 95% CI: 0.13-0.43, p<0.0001) compared with platinum-based chemotherapy in people with completely resected IB (tumor ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC. In an exploratory analysis, an improvement of central nervous system (CNS)-disease-free survival (DFS) was observed (HR=0.22; 95% CI: 0.08-0.58). The safety and tolerability of Alecensa in this trial were generally consistent with previous trials in the metastatic setting and no unexpected safety findings were observed.
Clinical Profile and Testing Recommendations
Alecensa is a kinase inhibitor currently approved as first- and second-line treatment for ALK-positive metastatic NSCLC. It has demonstrated significant efficacy in patients, including those with CNS metastases, and now with this approval, these benefits could extend to people with early-stage disease. Routine testing for ALK, EGFR and PD-LK biomarkers is recommended by international guidelines to support clinical decision-making. About 5% of people with NSCLC are ALK-positive.
Regulatory Review Process
The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners. The FDA also reviewed and approved the supplemental application under its Real-Time Oncology Review pilot program. Data from the Phase III ALINA study will also be used for filing submissions to additional global health authorities.
