Posted by Michael Wonder on 28 Jul 2020
Black Diamond Therapeutics granted fast track designation by the FDA for BDTX-189 for the treatment of adult patients with a solid tumour harbouring an allosteric HER2 mutation or an EGFR or HER2 exon 20 insertion mutation
28 July 2020 - Black Diamond Therapeutics today announced that the U.S. FDA granted fast track designation to BDTX-189 for the treatment of adult patients with solid tumours harbouring 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 the Company’s 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.
