FDA grants Roche ALK inhibitor alectinib breakthrough status
This article was originally published in Scrip
Roche has gained breakthrough therapy designation from the US FDA for the company's experimental anaplastic lymphoma kinase (ALK) inhibitor alectinib (RO5424802/CH5424802), which is under investigation to treat patients with ALK-positive non-small-cell lung cancer (NSCLC) who have progressed following treatment with Pfizer's Xalkori (crizotinib).
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