Roche Holding AG got US Food and Drug Administration approval for expansion of lung cancer therapy Alecensa’s label to include adjuvant treatment of early-stage, anaplastic lymphoma kinase (ALK)-positive patients, making it the first drug to gain approval in that setting, but the revenue potential for the added indication appears to be fairly minimal.
Key Takeaways
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Roche gets US supplemental approval for Alecensa to treat adjuvant ALK-positive NSCLC, expanding a label that already includes first- and second-line therapy.
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The added indication may provide only minimal revenue growth, since ALK-positive patients comprise about 5% of the NSCLC caseload
Initially given accelerated approval in 2015 for second-line ALK-positive non-small cell lung cancer (NSCLC), Alecensa (alectinib) obtained full approval and a first-line therapy indication in the US in 2017. (Also see "Roche’s Alecensa Goes Up Against Zykadia with First-Line NSCLC US FDA Approval" - Scrip, 7 November, 2017.) Alecensa, which Roche subsidiary Chugai Pharmaceutical Co., Ltd
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