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Bayer's novel BAY 2927088 Granted FDA Breakthrough Status for HER2-Driven Non-Small Cell Lung Cancer

Bayer made a recent announcement stating that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088. This designation is for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) exhibiting activating HER2 mutations, who have previously undergone systemic therapy. BAY 2927088 is described as an oral, reversible tyrosine kinase inhibitor (TKI) that effectively inhibits mutant human epidermal growth factor receptors 2 (HER2) and epidermal growth factor receptors (EGFR), with a particular focus on mutant versus wild-type EGFR.

Lung cancer stands as the leading cause of cancer-related deaths globally, with NSCLC representing over 85% of cases. Activating HER2 mutations are identified in 2% to 4% of advanced NSCLC cases. Presently, there are no fully approved therapies in the U.S. for patients with NSCLC in the metastatic or advanced setting harboring HER2 activating mutations.

The Breakthrough Therapy designation is substantiated by preliminary clinical evidence from the Phase I study (NCT05099172), evaluating the safety, pharmacokinetics, and initial efficacy of BAY 2927088 in adult patients with advanced NSCLC harboring HER2 or EGFR mutations. Early indications suggest that BAY 2927088 has the potential to benefit patients with NSCLC harboring HER2 mutations who have progressed on prior systemic therapy, providing a novel treatment option where none currently exists.

This Breakthrough Therapy designation marks a noteworthy milestone in Bayer's commitment to developing innovative therapies for lung cancer characterized by specific genomic markers. The FDA's designation aims to expedite the development and review of drug candidates addressing serious or life-threatening diseases, especially when there's preliminary evidence indicating substantial improvement over existing therapies.

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