BRIEF—PharmaMar's Zepzelca gains full approval in Mexico

Spanish drugmaker PharmaMar says that its licensing partner, Adium Pharma, has received full approval for commercialization of Zepzelca (lurbinectedin) by the Federal Commission for the Protection against Sanitary Risks of Mexico (COFEPRIS) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

This new approval of lurbinectedin is based on the monotherapy clinical data from the open-label, multicenter, single-arm clinical trial in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive and platinum-resistant disease), that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the USA.

In March 2021, PharmaMar and Adium Pharma signed a licensing agreement for lurbinectedin in Latin America. The Mexican approval of lurbinectedin has been preceded for Adium by the approval in November 2022 also in Ecuador.

These approvals allow Adium Pharma to commercialize lurbinectedin in Ecuador and Mexico in the following months.   SCLC accounted for up to 15% of all lung cancer cases. Most SCLC patients are already at the advanced stage upon diagnosis, resulting in poor prognosis.