MADRID, 7 Nov. (EUROPA PRESS) -
Adium Pharma, a partner of PharmaMar, has received final marketing approval for lurbinectedin --zepzelca-- from the Ministry of Health of Peru for the treatment of adult patients with metastatic small cell lung cancer, with disease progression during or after platinum-based chemotherapy, as reported by the company to the National Securities Market Commission (CNMV) this Tuesday.
The firm has detailed that the approval of lurbinectedin in Peru is based mainly on data from an "open, multicenter, single-arm monotherapy" study carried out in 105 adult patients with recurrent metastatic small cell lung cancer, which also served as a basis to the Food and Drug Administration (FDA) to grant accelerated approval of lurbinectedin.
In March 2021, PharmaMar and Adium Pharma signed a licensing agreement for lurbinectedin in Latin America.
For its part, the approval of lurbinectedin in Peru has been preceded by the marketing authorization granted in Mexico and Ecuador.
With this approval, lurbinectedin is now authorized in 14 countries around the world.