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|Therapy Name||Ibrutinib + Palbociclib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Ibrutinib||Imbruvica||PCI-32765||BTK inhibitor 25 EGFR Inhibitor (Pan) 46 HER2 Inhibitor 26||Imbruvica (ibrutinib) is a selective, irreversible inhibitor of Bruton's tyrosine kinase (BTK), which promotes apoptosis and inhibits B-cell mediated signaling pathways, and has additional activity against ERBB2 (HER2) and EGFR (PMID: 20615965, PMID: 21422473, PMID: 27678331). Imbruvica (Ibrutinib) is FDA approved for use in patients with mantle cell lymphoma, CLL/SLL and CLL/SLL with del 17p, Waldenstroem’s macroglobulinemia, marginal zone lymphoma, and in combination with Rituxan (rituximab) for untreated CLL/SLL (FDA.gov).|
|Palbociclib||Ibrance||PD0332991||CDK4/6 Inhibitor 10||Ibrance (palbociclib) is a selective inhibitor of cyclin-dependent kinase 4 (CDK4) and 6 (CDK6) (PMID: 19874578). Ibrance (palbociclib) is approved in combination with an aromatase inhibitor in postmenopausal patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer, and in combination with Faslodex (fulvestrant) in patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||mantle cell lymphoma||not applicable||Ibrutinib + Palbociclib||Phase I||Actionable||In a Phase I trial, Imbruvica (ibrutinib) and Ibrance (palbociclib) combination treatment resulted in an overall response rate of 67%, a complete response rate of 37%, and a two year progression-free survival in 59.4% of patients with previously treated mantle cell lymphoma, with a median follow up of 25.6 months (PMID: 30692121; NCT02159755).||detail... 30692121|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03478514||Phase II||Ibrutinib + Palbociclib||Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma||Recruiting||USA||0|
|NCT02159755||Phase I||Ibrutinib + Palbociclib||Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma||Active, not recruiting||USA||0|