China approval for Zepzelca in SCLC
Spanish drugmaker PharmaMar Group (MSE: PHM) revealed that its licensing partner, Luye Pharma Group, has received conditional marketing approval for Zepzelca (lurbinectedin) from the China National Medical Products Administration (NMPA).
The drug is authorized for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression during or after platinum-based chemotherapy. China’s NMPA grants conditional approvals to medicines targeting diseases that are severely life-threatening and where there is no effective treatment, PharmaMar pointed out.
The NMPA conditional approval is based on the results from a single-arm, dose-escalation, dose-expansion clinical study conducted in China. The study was designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of lurbinectedin in Chinese patients with advanced solid tumors, including recurrent SCLC.
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