BRIEF—First approval in Europe for lurbinectedin

Spanish drugmaker PharmaMar says it has received the Temporary Authorization for the commercialization of Zepzelca (lurbinectedin) by the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy without central nervous system (CNS) metastases.

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, platinum-resistant and platinum refractory disease), that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the USA.

The temporary authorization is subject to confirmation with the LAGOON Phase III clinical trial in second-line SCLC, initiated in December 2021.