Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that Macau’s medical products administration bureau has approved a market approval filing for the firm’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients experiencing tumor progression during or after platinum-based chemotherapy.
The approval is supported by two clinical studies conducted in China and internationally. A single-arm, dose-escalation, and expansion clinical study in China demonstrated significant anti-tumor efficacy and manageable safety for lurbinectedin as a second-line treatment for Chinese SCLC patients, with an overall response rate (ORR) of 45.5% among subjects with recurrent SCLC, as evaluated by an independent committee. An open, multicenter, single-arm Phase II study overseas included 105 adult SCLC patients who developed disease progression after platinum chemotherapy, showing an ORR of 35% and a median duration of remission (DoR) of 5.3 months for those treated with lurbinectedin.
Lurbinectedin, discovered and developed by Spain-based Pharma Mar, S.A. (MCE: PHM), selectively inhibits oncogenic transcription, promoting tumor cell death and normalizing the tumor microenvironment. Luye acquired exclusive development and commercialization rights for lurbinectedin in China through a licensing deal with Pharma Mar in April 2019. The drug received conditional approval for SCLC treatment in the US in 2020 and has been approved in dozens of countries worldwide.- Flcube.com
