NDA accepted for lurbinectedin in China
“PharmaMar (MSE:PHM) and Luye Pharma Group Ltd. have announced today that the New Drug Application (NDA) submission of lurbinectedin has been accepted by the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in the People’s Republic of China (China) for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after receiving platinum-based chemotherapy. The NDA is based on data from a single-arm, dose-escalation, and dose-expansion clinical study conducted in China.”
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