PharmaMar's Zepzelca gains approval in Macao

Spanish drugmaker PharmaMar (MC: PHM) has announced that its licensing partner, Luye Pharma Group, has received marketing approval for Zepzelca (lurbinectedin) by the Pharmaceutical Administration Bureau in Macao for the treatment of adult patients with metastatic small-cell lung cancer (SCLC), with disease progression on or after platinum-based chemotherapy.

The approval of lurbinectedin in Macao is mainly based on data from two clinical trials. One based on the data from the open-label, multicenter, single-arm monotherapy clinical trial in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive and platinum-resistant disease), that the US Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin. The other, conducted in China, was a single-arm, dose-escalation, and dose-expansion clinical trial aiming to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of lurbinectedin in Chinese patients with advanced tumors, including relapsed SCLC.

In April 2019, PharmaMar and Luye Pharma signed an agreement for the development and commercialization of lurbinectedin in SCLC in mainland China, Hong Kong and Macao.