BDTX-189 has received Fast Track Designation from FDA for the treatment of adult patients with solid tumors harboring an allosteric human epidermal growth factor receptor 2 mutation or an epidermal growth factor receptor or HER2 Exon 20 insertion mutation who have progressed following prior treatment and who have no satisfactory treatment options.
BDTX-189, an orally available, irreversible small molecule inhibitor, is sponsored by Black Diamond Therapeutics, Inc. BDTX-189 is Diamond Therapeutics lead product candidate designed to selectively inhibit the activity of a broad range of previously unaddressed oncogenic driver mutations of the ErbB kinases in EGFR and HER2.
“While targeted therapies, such as kinase inhibitors, have transformed the treatment of cancer, only a small percentage of patients with metastatic cancer have tumors with genetic profiles that could make them eligible for an approved precision oncology medicine,” David M. Epstein, president and chief executive officer of Black Diamond Therapeutics, said in a statement.
