Black Diamond's BDTX-189 Fast Track'd for certain solid tumors (NASDAQ:BDTX
published 28.07.2020 10:54
The FDA has granted Fast Track designation to Black Diamond Therapeutics' (NASDAQ:BDTX) BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric HER2 mutation or EGFR or HER2 Exon 20 insertion mutation who have progressed following prior treatment and who have no satisfactory treatment options.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
BDTX-189, an oral 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.