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FDA Approves Roche Drugs For Rare Types Of Blood, Lung Cancers

(Reuters) Nov 6, 2017 - Roche Holding AG won U.S. approval to market its skin cancer drug Zelboraf for certain patients with Erdheim-Chester Disease, a rare type of blood cancer, and to market its drug Alecensa as a first choice of treatment for a subset of patients with non-small cell lung cancer.

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H. Jack West, MD (Posted: November 07, 2017)

quotesThe FDA approval for alectinib (Alecensa) as first line treatment for ALK-positive advanced NSCLC is long awaited and should make it a clear standard of care in this setting. The superiority of alectinib over the prior standard of care of crizotinib is remarkable, and alectinib also has highly superior efficacy vs. intracranial progression, which is a common issue in patients with ALK-positive NSCLC. It is also generally quite well tolerated by patients. Though we still need to learn more about how to best treat patients who develop acquired resistance to alectinib, whether that be with a subsequent ALK inhibitor like brigatinib or lorlatinib (which we hope to see approved in the first half of 2018) or a chemotherapy-based approach, the median PFS for alectinib of over 2 years suggests that we have some time to figure that out.quotes

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