The U.S. Food and Drug Administration (FDA) granted priority review to Genentech’s Alecensa (alectinib) as a first-line treatment for ALK-positive, locally advanced or metastatic NSCLC (non-small cell lung cancer). It also accepted the company’s supplemental new drug application (sNDA) for the therapy, and has set an action date of Nov. 30, 2017.
In December 2015, the FDA granted accelerated approval to Alecensa for patients with ALK-positive metastatic NSCLC who have not responded, or are intolerant, to Xalkori (crizotinib), which is the approved first-line therapy currently.
ALK (anaplastic lymphoma kinase)-positive lung cancer refers to a rare mutation in the ALK gene. It’s estimated that fewer than 7 percent of lung cancer patients have this gene abnormality. NSCLC is far more common, accounting for the majority of all lung cancers.
Genentech’s sNDA submission for Alecensa is based on results from the Phase 3 ALEX and Phase 3 J-ALEX studies.
“Phase 3 results showed Alecensa reduced the risk of disease worsening by more than half compared to the current standard of care and lowered the risk of tumors spreading or growing in the brain by more than 80 percent,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in a press release.
“We are working closely with the FDA to bring this medicine as an initial treatment for people with ALK-positive NSCLC as soon as possible,” she said.
The Phase 3 ALEX trial (NCT02075840) evaluated the effectiveness and safety of Alecensa compared to Xalkori. Patients were randomized to receive either treatment, and their progress was evaluated.
Results showed that Alecensa reduced the risk of disease worsening or death by 53% and increased progression-free survival compared to Xalkori. Alecensa also decreased risk of progression in the central nervous system by 84%. The 12-month rate of CNS progression for people on Alecensa was 9.4% vs. 41.4% for those on Xalkori.
Grade 3-5 adverse events also were shown to be lower in the Alecensa group compared to the Xalkori group, according to the trial results.
Similar results were obtained from the Phase 3 J-ALEX study, which was conducted in Japanese patients by Chugai, a biopharmaceutical company.
The FDA’s decision to approve Alecensa as a first-line therapy will be made based on whether it provides a significant improvement in safety and effectiveness over the current first-line treatment, Xalkori, for this disease.
Genentech is a leading biopharma that focuses on developing treatments for fatal or life-threatening medical diseases. Lung cancer is a major area of focus. Genentech is developing more than 10 therapies that are targeted for treating lung cancer.