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Bayer’s BAY 2927088 Granted FDA Breakthrough Therapy Designation for Lung Cancer

Early clinical evidence suggests that BAY 2927088 has the potential to benefit patients with NSCLC harboring a HER2 mutation.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Bayer for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy. BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant human epidermal growth factor receptors 2 (HER2), including HER2 exon 20 insertion...

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