New Drug Application for lurbinectedin accepted in China
The New Drug Application (NDA) submission for lurbinectedin has been accepted by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after receiving platinum-based chemotherapy.
The drug is marketed as Zepzelca by Spanish drugmaker PharmaMar (MC: PHM), under a licensing agreement with the USA’s Jazz Pharmaceuticals (Nasdaq: JAZZ). In April 2019, PharmaMar signed an agreement China-based Luye Pharma (SEHK: 2186) for the development and commercialization of lurbinectedin in SCLC, and potentially in other indications in mainland China, Hong Kong and Macao.
In 2020, Zepzelca received accelerated approval from the US Food and Drug Administration (FDA) and subsequently received approvals in nine other countries for the treatment of metastatic SCLC, and has been filed in several countries.
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