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Alecensa, alectinib (AF802, CH5424802, RG7853, RO5424802)

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Company Chugai Pharmaceutical Co. Ltd.
DescriptionAnaplastic lymphoma kinase (ALK) inhibitor
Molecular Target Anaplastic lymphoma kinase (ALK)
Mechanism of ActionAnaplastic lymphoma kinase (ALK) inhibitor
Therapeutic ModalitySmall molecule
Latest Stage of DevelopmentMarketed
Standard IndicationNon-small cell lung cancer (NSCLC)
Indication DetailsTreat advanced ALK-positive non-small cell lung cancer (NSCLC); Treat ALK-positive, metastatic NSCLC in patients who have progressed on or are intolerant to crizotinib; Treat non-small cell lung cancer (NSCLC); Treat unresectable progressive or recurrent ALK-positive non-small cell lung cancer (NSCLC)
Regulatory Designation U.S. - Accelerated Approval (Treat ALK-positive, metastatic NSCLC in patients who have progressed on or are intolerant to crizotinib);
U.S. - Breakthrough Therapy (Treat advanced ALK-positive non-small cell lung cancer (NSCLC));
U.S. - Orphan Drug (Treat advanced ALK-positive non-small cell lung cancer (NSCLC));
U.S. - Priority Review (Treat advanced ALK-positive non-small cell lung cancer (NSCLC));
Japan - Orphan Drug (Treat unresectable progressive or recurrent ALK-positive non-small cell lung cancer (NSCLC));
Japan - Standard Review (Treat advanced ALK-positive non-small cell lung cancer (NSCLC))
PartnerGenentech Inc.;
Roche

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