Currently approved in 9 other countries
In April 2019, PharmaMar and Luye Pharma signed an agreement for the development and commercialization of lurbinectedin in small cell lung cancer and potentially other indications in mainland China, Hong Kong and Macau.
![[Img # 52852]](https://empresaexterior.com/upload/images/06_2023/8327_farmaceutico_cr.jpg)
PharmaMar y Luye Pharma Group Ltd. have announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People's Republic of China has accepted the New Drug Application (NDA) for approval of lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer with disease progression during or after receiving platinum-based chemotherapy.
In April 2019, PharmaMar and Luye Pharma signed an agreement for the development and commercialization of lurbinectedin in small cell lung cancer and potentially in other indications in Mainland China, Hong Kong and Macau.
In 2020, lurbinectedin received accelerated approval from the FDA and is currently approved in 9 other countries for the treatment of small cell lung cancer. In addition, the registration dossier has been presented in several countries.
This application is based on data from a single-arm, dose-escalation, and 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 small cell lung cancer. The results of the study show a manageable efficacy and safety profile of the drug as second-line therapy at a dose of 3,2 mg/m2 in Chinese patients with this type of tumor, the same dose that has been approved in the United States and in other countries. An Independent Review Committee confirmed that the Overall Response Rate (ORR) was 45,5% in subjects with this pathology.
The clinical study conducted in China was the first to evaluate the efficacy and safety of lurbinectedin in Chinese patients. Preliminary results of this study were presented at the 2022 annual meeting of the American Society of Clinical Oncology (ASCO), as well as at the 25th National Conference of Clinical Oncology and at the 2022 annual meeting of the Chinese Society of Clinical Oncology.
In addition to mainland China, lurbinectedin is also being reviewed for registration in the regions of Hong Kong and Macau (China) and received authorization from the authorities of the Chinese province of Hainan and Hong Kong for compassionate use.
Lung cancer was the tumor with the highest incidence in China in 2020 in terms of morbidity and mortality, with approximately 815.000 new cases and 714.000 deaths that year[1]. Specifically, small cell lung cancer represented between 13% and 17% of all lung cancer cases. Most of these patients were already in an advanced stage at the time of diagnosis, which translated into a poor prognosis. Their five-year survival rate was only 7%, or just 3% for patients with advanced disease. Although small cell lung cancer is very sensitive to initial treatments, most patients relapsed or developed drug resistance after initial treatments. According to statistics, approximately 75% of patients with locally advanced tumor and more than 90% of patients with metastasis relapsed within two years of receiving treatment. The high relapse rate poses a significant challenge for its treatment, so innovative therapies are urgently needed in clinical practice.
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