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Title Xalkori (crizotinib) FDA Drug Label
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URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202570
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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Crizotinib Crizotinib 160 34
Drug Name Trade Name Synonyms Drug Classes Drug Description
Crizotinib Xalkori PF-02341066 ALK Inhibitor 24 MET Inhibitor 54 RON Inhibitor 10 ROS1 Inhibitor 15 Xalkori (crizotinib), inhibits ALK kinase, ALK fusion proteins, c-Met, ROS1 fusion proteins, and MST1R (RON), resulting in growth inhibition of tumor cells (PMID: 26951079, PMID: 22617245). Xalkori (crizotinib) is FDA approved for use in patients with ALK or ROS1 positive (rearrangements and fusions) non-small cell lung cancer, and in pediatric patients 1 year and older and young adults with relapsed or refractory, ALK-positive systemic anaplastic large cell lymphoma (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ALK rearrange lung non-small cell carcinoma sensitive Crizotinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROFILE 1014) that supported FDA approval, Xalkori (crizotinib) treatment resulted in improved progression-free survival (10.9 vs 7.0 months, HR=0.45, p<0.001) and objective response rate (74% vs 45%) relative to chemotherapy in NSCLC patients with ALK rearrangements (PMID: 25470694; NCT01154140). detail... 25470694 detail...
ALK fusion anaplastic large cell lymphoma sensitive Crizotinib FDA approved Actionable In a Phase I/II trial that supported FDA approval, Xalkori (crizotinib) treatment resulted in an objective response rate (ORR) of 83% (5/6, all complete responses (CR)) at the 165 mg dose, and an ORR of 90% (18/20, 16 CR) at the 280 mg dose, in pediatric patients 1 years of age or older and young adults with relapsed or refractory ALK-positive anaplastic large cell lymphoma (PMID: 28787259; NCT00939770). 28787259 detail...
ALK fusion lung non-small cell carcinoma sensitive Crizotinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (PROFILE 1014) that supported FDA approval, Xalkori (crizotinib) treatment resulted in improved progression-free survival (10.9 vs 7.0 months, HR=0.45, p<0.001) and objective response rate (74% vs 45%) relative to chemotherapy in NSCLC patients with ALK rearrangements (PMID: 25470694; NCT01154140). 25470694 detail... detail...
ALK rearrange anaplastic large cell lymphoma sensitive Crizotinib FDA approved Actionable In a Phase I/II trial that supported FDA approval, Xalkori (crizotinib) treatment resulted in an objective response rate (ORR) of 83% (5/6, all complete responses (CR)) at the 165 mg dose, and an ORR of 90% (18/20, 16 CR) at the 280 mg dose, in pediatric patients 1 years of age or older and young adults with relapsed or refractory ALK-positive anaplastic large cell lymphoma (PMID: 28787259; NCT00939770). 28787259 detail...
ROS1 fusion lung non-small cell carcinoma sensitive Crizotinib FDA approved - On Companion Diagnostic Actionable In a Phase I trial that supported FDA approval, Xalkori (crizotinib) treatment resulted in an objective response rate of 72% (36/50), with 3 complete responses and 33 partial responses, a median duration of response of 17.6 months, and a median progression-free survival of 19.2 months in patients with non-small cell lung cancer harboring ROS1 rearrangements as detected by an FDA-approved test (PMID: 25264305; NCT00585195). detail... 25264305 detail...
ROS1 rearrange lung non-small cell carcinoma sensitive Crizotinib FDA approved - On Companion Diagnostic Actionable In a Phase I trial (PROFILE 1001) that supported FDA approval, Xalkori (crizotinib) treatment resulted in an objective response rate of 72% (38/53), with 6 complete responses and 32 partial responses, a median duration of response of 24.7 months, a median progression-free survival of 19.3 months, and a median overall survival of 51.4 months in patients with non-small cell lung cancer harboring ROS1 rearrangements as detected by an FDA-approved test (PMID: 30980071; NCT00585195). detail... detail... 30980071