Bayer gets Breakthrough Therapy designation in China for lung cancer drug BAY 2927088
Berlin: Bayer has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has granted Breakthrough Therapy designation for BAY 2927088, a potential new targeted therapy for 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.
The CDE’s designation for BAY 2927088 follows the Breakthrough Therapy designation granted by the U.S. Food and Drug Administration (FDA) in February 2024 for the same patient population.
“The Breakthrough Therapy designations granted for BAY 2927088 by China's CDE and the U.S. FDA underscore the potential of this targeted therapy to transform the lives of patients with HER2-mutant NSCLC, a type of lung cancer with limited treatment options and often poor prognosis,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “This recognition, backed by promising clinical evidence, strengthens our commitment to addressing critical unmet needs in cancer care. It reinforces our mission to be a leader in oncology by accelerating the development of targeted therapies, one of our key focus areas.”
This Breakthrough Therapy designation is supported by preliminary clinical evidence from the Phase I/II, open-label, multicenter first-in-human study (NCT05099172) evaluating the safety, pharmacokinetics and preliminary efficacy of BAY 2927088 in adult patients with advanced NSCLC harboring HER2 or EGFR. The Breakthrough Therapy designation is a process designed to expedite the development and review of novel medicines that are intended for the prevention or treatment of serious, life-threatening diseases or conditions that severely impact the quality of life for which there is no existing treatment, or where sufficient evidence indicates advantages of the novel drug over available treatment options.
BAY 2927088 is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring HER2 activating mutations. 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 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR.
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