Bayer announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has granted 'Breakthrough Therapy' designation to BAY 2927088, a potential new targeted therapy for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have HER2-activating mutations (ERBB2) and who have already received systemic therapy.

BAY 2927088 is an oral small molecule inhibitor in development as a potential new targeted therapy for patients with this lung cancer.

The Center for Drug Evaluation in China has granted Breakthrough Therapy designation to accelerate the development and review of BAY 2927088, given its potential to provide a substantial advantage over available therapies in an area of high unmet need.

The CDE designation for BAY 2927088 follows 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 to BAY 2927088 by the Chinese CDE and the U.S. FDA underscore the potential of this targeted therapy to transform the lives of patients with HER2-mutated NSCLC, a type of lung cancer with limited treatment options and an often dismal prognosis,'' said Christian Rommel, Ph.D., Head of Research and Development at Bayer's Pharmaceutical Division.

' This recognition, backed by promising clinical evidence, reinforces 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 areas of focus'.

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