FDA approves Alecensa for certain patients with ALK-positive lung cancer
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The FDA approved alectinib as an adjuvant treatment for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer following tumor resection and detection by an FDA-approved test.
Alectinib (Alecensa, Genentech), a kinase inhibitor, gained approval based on results of a phase 3 randomized trial that showed prolonged disease-free survival (DFS) compared with chemotherapy.
“With an unprecedented 76% reduction in the risk [for] disease recurrence or death versus chemotherapy, Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in a press release.
Patients in the open-label ALINA study had between stage IB and IIIA NSCLC that could be resected, as well as identifiable ALK mutations.
Researchers randomly assigned the 257 participants in a 1:1 ratio to receive alectinib or platinum-based chemotherapy following resection.
Median DFS had not been reached in the treatment arm, whereas the chemotherapy arm had a median DFS of 41.3 months (HR = 0.24; 95% CI, 0.13-0.43).
Common adverse events reported during the ALINA study included hepatotoxicity, constipation, myalgia, COVID-19, fatigue, rash and cough. Patients taking alectinib could be more sensitive to sunlight and get sunburned easier, according to the manufacturer’s release.
They “should avoid spending time in the sunlight during treatment with Alecensa and for 7 days after the last dose,” Genentech advised.
The recommended dose is 600 mg, which should be taken twice a day orally with food for 2 years. Treatment should stop if the cancer returns, or toxicity becomes unacceptable.
“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, MD, director of research and clinical affairs at ALK Positive, said in the press release. “These patients, who are typically diagnosed at a younger age, often face recurrence and have a higher risk [for] 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.”
References:
- FDA. FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-alectinib-adjuvant-treatment-alk-positive-non-small-cell-lung-cancer. Posted April 18, 2024. Accessed April 19, 2024.
- Genentech. FDA approves Genentech’s Alecensa as first adjuvant treatment for people with ALK-positive early-stage lung cancer. Available at: https://www.gene.com/media/press-releases/15023/2024-04-18/fda-approves-genentechs-alecensa-as-firs. Posted April 18, 2024. Accessed April 19, 2024.
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