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FDA approves Roche’s alectinib product

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Nov. 27, 2017Roche announced that the FDA approved the supplemental new drug application for Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer as detected by an FDA-approved test.

The approval is based on results from the phase III Alex study, which showed Alecensa significantly reduced the risk of disease worsening or death (progression-free survival) by 47 percent compared to crizotinib as assessed by independent review committee. Median PFS was 25.7 months for people who received Alecensa compared with 10.4 months for people who received crizotinib. The safety profile of Alecensa was consistent with that observed in previous studies. The study also showed that Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or central nervous system compared with crizotinib by 84 percent. This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12 percent) compared with people who received crizotinib (45 percent).

The FDA also converted Alecensa’s initial accelerated approval in December 2015 for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second line) to a full approval.

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