OncoKB New Data Release - May 29, 2026
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Data Release v7.2
May 29, 2026
What's New
Release of OncoKB™ SOP v6.2
Update to our FDA Cleared or Approved Companion Diagnostic Devices (CDx) page
Update to our FDA-Approved Oncology Therapies page
Updated Therapeutic Implications:
New alteration(s) with a cancer type-specific level of evidence
Level 1 - Somatic: ESR1 L549P in breast cancer based on FDA approval of vepdegestrant (PMID: 40454645)
Level 3A - Somatic: BTK C481S, C481F, C481R and C481Y in chronic lymphocytic leukemia/small lymphocytic lymphoma based on promising clinical evidence of responses for pirtobrutinib in patients with BTK-mutant chronic lymphocytic leukemia/small lymphocytic lymphoma (PMID: 33676628)
Level 4 - Somatic: CDK4 Amplification in uterine sarcoma based on NCCN-compendium listing of palbociclib for patients with CDK4-amplified uterine sarcoma, though no responses were observed in this cancer type (PMID: 37875500)
Level R2 - Somatic: ALK I1171S, V1180L and L1196Q in non-small cell lung cancer based on identification in ALK fusion-positive non-small cell lung cancers following disease progression on alectinib (PMID: 27009859, 26464158, 25393796, 25228534, 37907052, 30662002, 33209633, 31712133)
Level R2 - Somatic: ALK T1151M in non-small cell lung cancer based on identification in ALK fusion-positive non-small cell lung cancers following disease progression on crizotinib (PMID: 27009859, 30892989)
Level R2 - Somatic: EGFR T854A in non-small cell lung cancer based on identification in EGFR L858R-mutant non-small cell lung cancers following disease progression on erlotinib (PMID: 19010870, 26041145)
Level R2 - Somatic: MET D1228H in non-small cell lung cancer based on identification in MET D1228H-mutant non-small cell lung cancers following disease progression on capmatinib (PMID: 35690785, 39180576)
Level R2 - Somatic: RET G810C, G810S and G810R in non-small cell lung cancer based on identification in RET-mutant non-small cell lung cancers following disease progression on selpercatinib (PMID: 37070927, 31988000, 33161056)
Promotion of cancer type-specific level of evidence for an alteration
Level 1 - Somatic: NRG1 Fusions in cholangiocarcinoma promoted from Level 2 to Level 1 based on FDA approval of zenocutuzumab for NRG1-fusion positive cholangiocarcinoma (PMID: 39908431)
Level 1 - Somatic: ESR1 K303R in breast cancer promoted from Level 3A to Level 1 based on FDA approval of vepdegestrant (PMID: 40454645)
Level R1 - Somatic: BTK C481F, C481R and C481Y in chronic lymphocytic leukemia/small lymphocytic lymphoma promoted from Level R2 to Level R1 based on identification in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma following disease progression on ibrutinib, acalabrutinib and zanubrutinib (PMID: 39908431, 26182309, 30508305, 35639855, 39853273, 27282255, 28049639, 27571029, 38754046; Abstract: Woyach, J. et al. Abstract# 642.CLL, Blood. 2019)
Addition of drug(s) associated with an existing cancer type-specific alteration with an assigned OncoKB™ level of evidence, without changing the alteration's highest level of evidence
Level 1 - Somatic: Addition of Vepdegestrant to ESR1 V422del in breast cancer based on FDA approval of vepdegestrant (PMID: 40454645)
Level 1 sensitivity-associated therapeutics currently in OncoKB™ for ESR1 V422del in breast cancer: Imlunestrant
Level 1 - Somatic: Addition of Vepdegestrant to ESR1 D538, E380, Y537, L536, L469V, S463P and S463F in breast cancer based on FDA approval of vepdegestrant (PMID: 40454645)
Level 1 sensitivity-associated therapeutics currently in OncoKB™ for ESR1 D538, E380, Y537, L536, L469V, S463P and S463F in breast cancer: Imlunestrant, Elacestrant
Level 1 - Somatic: Addition of Vepdegestrant to ESR1 Oncogenic Missense Mutations in the Ligand Binding Domain (LBD) in breast cancer based on FDA approval of vepdegestrant (PMID: 40454645)
Level 1 sensitivity-associated therapeutics currently in OncoKB™ for ESR1 Oncogenic Missense Mutations in the LBD in breast cancer: Elacestrant
Level R1 - Somatic: Addition of Ibrutinib to BTK C481S in chronic lymphocytic leukemia/small lymphocytic lymphoma based on identification in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma following disease progression on ibrutinib (PMID: 38754046, 38301010, 35639855, 39853273)
Level R1 resistance-associated therapeutics currently in OncoKB™ for BTK C481S in chronic lymphocytic leukemia/small lymphocytic lymphoma: Acalabrutinib, Zanubrtuinib
Addition of 4 new genes
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