Genetech, a member of the Roche Group, had announced that U.S. Food and Drug Administration (FDA) has approved Alecensa (alectinib) for adjuvant treatment of patients with early stage, anaplastiv lymphoma kinase-positive non-small cell lung cancer who have undergone tumor Resection. With this approval, Alecensa is the first and only ALK inhibitor approved for this indication, according to Genentech. The drug is currently approved in more than 100 countries including U.S. as an initial and second-line treatment for that kind of lung cancer.
This approval is backed by data from the Phase III ALINA trial, a randomized, active-controlled and open-label study comparing adjuvant Alecensa with platinum-based chemotherapy. In the study, 257 patienys were enrolled with Stage IB to IIIA tumors who had undergone Resection and tested positive for ALK. The results were released in October last year and showed that Alecensa could cut the risk of lung cancer recurrence or death by 76% versus platinum-based chemotherapy.
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development said, “At Roche, 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.”
Alecensa is a small molecule drug that works by blocking the action of ALK protein, which in non-small cell lung cancer is mutated and leads to the uncontrolled growth of cells. Alecensa has demonstrated significant efficacy in patients including those with CNS metastases, and this approval extends the benefits to people with early-stage disease as well.
The information shared in this blog is for educational purposes only. You should always consult with your healthcare provider for any medical needs.
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