OncoKB New Data Release - May 1, 2024
Contact OncoKB
Data Release v4.16
May 1, 2024
What's New
Release of the “FDA Cleared or Approved Companion Diagnostic Devices” (CDx) page, which includes information about companion diagnostics that are listed in FDA-drug labels of OncoKB™ level 1 precision oncology drugs.
We have updated our FAQ page with the most commonly asked questions of 2023. Take a look at what our users are asking us.
Updated Therapeutic Implications:
Promotion of the tumor type-specific level of evidence for an alteration
Level 1: BRAF Fusions in low-grade glioma promoted from Level 3B to Level 1 based on FDA-approval of tovorafenib for pediatric low-grade gliomas harboring a BRAF fusion or rearrangement (PMID: 37978284)
Level 1: BRAF V600 (excluding V600E) mutations in low-grade glioma promoted from Level 3B to Level 1 based on FDA-approval of tovorafenib for BRAF V600-mutant pediatric low-grade gliomas (PMID: 37978284)
Level 2: ERBB2 Amplification in salivary gland cancer promoted from Level 3B to Level 2 based on inclusion of trastuzumab, trastuzumab + docetaxel, ado-trastuzumab emtansine, trastuzumab deruxtecan and trastuzumab + pertuzumab as treatment recommendations for HER2-positive (IHC 3+) salivary gland cancer in the NCCN Head and Neck Cancer Guidelines V3.2024 (PMID: 28006087, 30452336, 31504139, 38231777, 32067683; Abstract: Liu, D. et al. Abstract# 3025, JCO 2023.)
Level 3A: ERBB2 Amplification in all solid tumors (excluding Breast Cancer, Esophagogastric Cancer, and Colorectal Cancer where ERBB2 amp remains Level 1; Biliary Tract Cancer, Salivary Gland Cancer, and Uterine Cancer where ERBB2 amp remains Level 2) promoted from Level 3B to Level 3A based on FDA-approval of trastuzumab deruxtecan for HER2-positive (IHC 3+) solid tumors and clinical trials of trastuzumab deruxtecan demonstrating efficacy in various HER2-expressing (IHC 3+) solid tumors (PMID: 37870536, 38547891, 37286557)
Addition of therapy(s) associated with a tumor type-specific leveled alteration(s) (without changing the alteration's highest level of evidence)
Level 1: Tovorafenib added as a treatment for BRAF V600E in low-grade glioma based on FDA-approval of tovorafenib for BRAF V600-mutant pediatric low-grade gliomas (PMID: 37978284)
Drug(s) currently in OncoKB™: Dabrafenib + Trametinib (Level 1)
Gene Curation:
Addition of 7 new genes:
FGF7 FOLR1 GRB7 MTHFD2 MYO5A SLIT3 UCHL1
We're Here to Help
As always, don’t hesitate to reach out if you have comments, questions or suggestions. We love to hear from you. You can reach us at con...@oncokb.org
