Chinese health authorities approve lurbinectedin for “urgent clinical use”

PharmaMar’s partner in China, Luye Pharma Group Ltd, obtains permission from the Hainan regional health authorities to open an Expanded Access Program for Zepzelca® PharmaMar (MSE:PHM) has announced today that its partner in China, Luye Pharma Group Ltd., has obtained permission from the Hainan health authorities to open a compassionate use program for lurbinectedin for the treatment of Small Cell Lung Cancer (“SCLC”). Lung cancer is a malignant tumor with high morbidity and mortality rates in China, and SCLC is an aggressive high-grade neuroendocrine carcinoma that accounts for 13%–17% of all lung cancer cases. According to the International Agency for Research on Cancer (“IARC”), lung cancer had higher morbidity and mortality rates than other malignant tumors in China in 2020, with 815,000 new lung cancer cases and 714,000 deaths reported that year. The IARC also predicted that in 2022 the number of new SCLC cases in China will exceed 110,000. The opening of an Expanded Access Program for lurbinectedin to be used in Hainan means that Luye Pharma Group Ltd will be the first company to bring a new treatment option to SCLC patients in China who urgently need effective treatments. In June 2020, lurbinectedin received “Accelerated Approval” from the FDA for the treatment of adult patients with metastatic SCLC with disease progression and is already the standard of care in the US. Lurbinectedin has also received marketing authorization in the United Arab Emirates, Canada, Australia and Singapore, and more recently in Qatar.

The release as fetched from its publisher. pharmamar.com ↗