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The US FDA Grants Fast Track Designation to BridgeBio Oncology Therapeutics’ BBO-8520 for KRASG12C-Mutated Metastatic Non-Small Cell Lung Cancer

Shots:

  • The US FDA has granted FTD to BBO-8520 for the treatment of metastatic NSCLC with KRAS^G12C mutations in adults
  • BBO-8520 showed significant tumor inhibition in preclinical models, post resistance to sotorasib.  In addition, BBO-8520 is being assessed in a P-I (ONKORAS-101) trial in KRAS^G12C NSCLC patients either receiving KRAS^G12C inhibitors or no targeted therapy before
  • BBO-8520 inhibits both “ON & OFF” states of KRASG12C, targeting resistance mechanisms like KRAS^G12C amplification & RTK activation. Developed via NCI RAS Initiative, Lawrence Livermore National Laboratory, & BBOT collaboration

Ref: BridgeBio Oncology Therapeutics | Image: BridgeBio Oncology Therapeutics

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