Bayer Granted FDA Breakthrough Therapy Designation for Non-Small Cell Lung Cancer Drug

Pharmaceutical Executive February 26, 2024
Davy James

BAY 2927088 is an oral, reversible small molecule tyrosine kinase inhibitor being analyzed for the treatment of unresectable or metastatic non-small cell lung cancer with tumors that have activating HER2 mutations.

Bayer’s novel small molecule tyrosine kinase inhibitor (TKI) BAY 2927088 has been granted Breakthrough Therapy designation by the FDA to treat unresectable or metastatic non-small cell lung cancer (NSCLC) with tumors that have activating human epidermal growth factor receptor 2 (HER2) mutations in patients who were previously administered systemic therapy.¹ The oral, reversible TKI is a highly potent and selective inhibitor of HER2 exon 20 insertions, HER2 point mutations, and epidermal growth factor receptors (EGFR).

“Early clinical evidence suggests that BAY 2927088, our investigational novel oral tyrosine kinase inhibitor,...

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