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Bayer's New Lung Cancer Drug Receives Critical FDA Breakthrough Designation


1 March 2024

Bayer announced that its investigational drug BAY 2927088 has been awarded the Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA). This promising development brings new hope to patients battling non-small cell lung cancer (NSCLC) with specific HER2 activating mutations, offering a potential new avenue for treatment. Patients with this mutation have limited treatment options, especially in the metastatic or advanced stages of the disease.

BAY 2927088 represents a significant advancement in targeted cancer therapy as an oral, reversible tyrosine kinase inhibitor (TKI), focusing on the inhibition of mutant human epidermal growth factor receptor 2 (HER2), including HER2 exon 20 insertions and point mutations, as well as epidermal growth factor receptors (EGFR) with notable selectivity for mutant over wild-type EGFR.

This approach targets mutations found in 2% to 4% of advanced NSCLC cases, a critical development given that NSCLC is the most prevalent type of lung cancer, accounting for over 85% of instances and leading the causes of cancer-related deaths worldwide. The FDA's Breakthrough Therapy designation for BAY 2927088 underlines its potential impact in a field with a high unmet medical need.

The FDA's Breakthrough Therapy designation showcases the potential of BAY 2927088, supported by preliminary clinical evidence from an ongoing Phase I study. This study evaluates the safety, pharmacokinetics, and preliminary efficacy of the drug in adults with advanced NSCLC harboring HER2 or EGFR mutations.

According to Dr. Dominik Ruettinger, Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division, early clinical trials suggest that BAY 2927088 could offer substantial benefits to patients who have seen their disease progress despite previous treatments. 

He stated “This Breakthrough Therapy designation is a significant milestone in our relentless efforts to develop innovative therapies for the treatment of lung cancer characterized by specific genomic markers. We will continue working closely with the FDA to advance BAY 2927088 through the clinic and look forward to providing these patients with lung cancer and their physicians with a targeted, effective treatment option.”

This development could not only provide a new targeted treatment option for patients with NSCLC but also pave the way for further innovations in the treatment of cancers with specific genomic profiles.

BAY 2927088 was derived from Bayer’s long-standing strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.

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