- Lurbinectedin is a new chemical compound with a novel mechanism of action. It’s been the only new chemical entity approved by the U.S. FDA for the treatment of relapsed SCLC over the past 26 years.
- Lurbinectedin has been approved in Hong Kong and Macao. Its NDA is also under review in Chinese mainland, where patients will be able to get access to this innovative therapy soon at designated healthcare institutions in Guangdong via the Greater Bay Area Initiative.
Shanghai, China, December 12, 2023 – Luye Pharma Group today announced that ZEPZELCA®(Lurbinectedin) has been approved by the Pharmacy and Poisons Board of the Hong Kong Special Administrative Region (SAR) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression upon or after receiving platinum-based chemotherapy.
Lurbinectedin is a new chemical compound with a novel mechanism of action. In 2020, it received the accelerated approval from the U.S. Food and Drug Administration (FDA) for the above indication. It was the only new chemical entity approved by the FDA for the treatment of relapsed SCLC during the 26-year period after 1997.
The approval of Lurbinectedin in Hong Kong is based on a study conducted overseas. It was an open-label, multicenter, and single-arm Phase II clinical trial in 105 adult patients with SCLC whose condition progressed after receiving the platinum-based chemotherapy. This study also provided evidence for the accelerated approval of Lurbinectedin in the U.S. In this study, patients treated with Lurbinectedin demonstrated an overall response rate (ORR) of 35.2%, and a median duration of response (DoR) of 5.3 months.
Dr. Leung Kwong Chuen, Clinical Oncologist and Clinical Associate Professor (Honorary) at the Department of Medicine and Therapeutics of the Chinese University of Hong Kong said:” In Hong Kong, lung cancer has the highest mortality rate among all cancers, especially SCLC, which is notoriously difficult to treat because it’s highly malignant and invasive. Most patients would develop drug resistance and experience a relapse after receiving the initial treatment. Meanwhile, there has been very limited progress in the treatment of this disease, with almost no substantial breakthrough in more than two decades. The approval of Lurbinectedin will provide a new treatment option for physicians. I believe that this drug will become a new second-line treatment for SCLC, to help improve patient outcomes.”
In addition to its approval in Hong Kong and Macao, Lurbinectedin is also under review for its New Drug Application (NDA) in Chinese mainland. Moreover, the drug has been granted a priority review status by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). Lurbinectedin is recommended by multiple authoritative guidelines in China and abroad, including the NCCN Guidelines for SCLC (V1. 2024), which recommends this drug as a preferred treatment for SCLC patients with a chemotherapy-free interval (CTFI) ≤ 6 months, and the 2023 CSCO Guidelines for SCLC, which recommends it as a second-line treatment for SCLC relapsed within or after 6 months.
Yang Rongbing, President of Luye Pharma Group, said: "Lung cancer is the No.1 malignant cancer in China in terms of morbidity and mortality rates, and SCLC is a subtype of lung cancer that is relatively difficult to treat. It is pressing to address the unmet treatment needs of patients. We're excited to see the approval of Lurbinectedin in Hong Kong shortly after its approval in Macao. We’ll take multiple measures simultaneously to make Lurbinectedin available to more patients by, for example, taking advantage of the Greater Bay Area Initiative, which is designed to make pharmaceuticals and medical devices registered in Hong Kong and Macao available to patients throughout the Guangdong-Hong Kong-Macao Greater Bay Area."
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