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|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|ALK rearrange||lung non-small cell carcinoma||sensitive||Ceritinib||FDA approved - On Companion Diagnostic||Actionable||In a Phase I trial that supported FDA approval, Zykadia (ceritinib) resulted in a blinded independent review committee (BIRC)-assessed objective response rate of 44% (72/163) and a duration of response of 7.1 months in ALK-rearranged non-small cell lung cancer patients (PMID: 25754348; NCT01283516).||25754348 detail... detail...|
|ALK rearrange||lung non-small cell carcinoma||sensitive||Ceritinib||Guideline||Actionable||Zykadia (ceritinib) is included in guidelines as first-line and as subsequent therapy for patients with advanced or metastatic ALK-rearranged non-small cell lung cancer (NCCN.org).||detail...|
|ALK rearrange||lung non-small cell carcinoma||sensitive||Ceritinib||Clinical Study - Cohort||Actionable||In a retrospective analysis, non-small cell lung cancer patients with brain metastases harboring an ALK rearrangement demonstrated a median overall survival of 49.5 months following treatment with the combination of an ALK-targeted tyrosine kinase inhibitor, including Zykadia (ceritinib), and radiotherapy (PMID: 26438117).||26438117|
|ALK rearrange||lung non-small cell carcinoma||sensitive||Ceritinib||Guideline||Actionable||Zykadia (ceritinib) is included in guidelines for patients with metastatic non-small cell lung cancer harboring an ALK rearrangement (PMID: 30715168, PMID: 30285222; ESMO.org).||30715168 detail... 30285222|
|ALK rearrange||lung non-small cell carcinoma||sensitive||Ceritinib||Phase II||Actionable||In a Phase II trial (ASCEND-2), non-small cell lung cancer patients with brain metastases harboring an ALK rearrangement and previously treated with Xalkori (crizotinib) and chemotherapy demonstrated an overall response rate of 38.6% (54/140), a disease control rate of 77.1%, a median time to response of 1.8 months, a median duration of response of 9.7 months, and a median progression-free survival of 5.7 months when treated with Zykadia (ceritinib) (PMID: 27432917; NCT01685060).||27432917|
|PubMed Id||Reference Title||Details|
|(26438117)||Extended Survival and Prognostic Factors for Patients With ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastasis.||Full reference...|
|(27432917)||Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2.||Full reference...|
|(25754348)||FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer.||Full reference...|
|ESMO Clinical Practice Guidelines||Full reference...|
|(30715168)||Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.||Full reference...|
|(30285222)||Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.||Full reference...|
|Zykadia (ceritinib) FDA Drug Label||Full reference...|