FDA Fast Track Designation for BH-30643 for the Treatment of Advanced EGFR C797S-positive NSCLC
“Fast Track designation is an important regulatory milestone and reflects FDA’s recognition, based on its review of our preliminary data, of the potential for BH-30643 to address a significant unmet medical need in this molecularly defined population, for which no oral targeted therapies are approved,” said Geoff Oxnard, M.D., Chief Medical Officer of BlossomHill Therapeutics. “Receiving this designation reaffirms our confidence in the development strategy for BH-30643 as a novel EGFR inhibitor designed to overcome C797S-mediated resistance. It also provides opportunities for more frequent engagement with FDA and potential access to other expedited programs, including potential eligibility for rolling review and accelerated approval, if applicable criteria are met.”
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