On December 4, 2023 PharmaMar (MSE:PHM) reported that its licensing partner, Luye Pharma Group Ltd, 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 (Press release, PharmaMar, DEC 4, 2023, View Source [SID1234638114]).
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The approval of lurbinectedin in Macao is mainly based on data from two clinical trials. One based on the data from the open-label, multi-center, single-arm monotherapy 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. 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.
Lurbinectedin is now approved in 14 countries around the world plus Macao. In the meantime, lurbinectedin Marketing Authorisation applications are under review for approval in Hong Kong and mainland China.
Lung cancer is the most common of all cancers in China in terms of incidence and mortality. In 2020, there were about 815,000 new cases of lung cancer and 714,000 deaths[1] caused by it, of which SCLC accounted for 13-17%[2].