FDA Fast Track Designation for BBO-8520 for KRASG12C-Mutated Metastatic NSCLC
“Receiving Fast Track designation for BBO-8520 is a significant milestone in our efforts to overcome the limitations of existing therapies for KRASG12C-mutant cancers,” said Yong Ben, MD, Chief Medical and Development Officer of BridgeBio Oncology Therapeutics. “BBO-8520 represents a first-in-class approach with potential to address high unmet medical needs and shift the paradigm for cancer treatment. We will continue to work closely with the FDA to expedite the development of BBO-8520, which is currently being evaluated in a Phase 1 study (NCT06343402) of KRASG12C NSCLC patients pre-treated with first generation KRASG12C “OFF” inhibitors or with no prior KRASG12C targeted therapy experience.”
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