PharmaMar receives approval of Zepzelca for the treatment of metastatic small cell lung cancer in Macau, China
December 05, 2023 at 09:00 am EST
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PharmaMar (MSE: PHM) today announced that its partner, Luye Pharma Group Ltd, has received marketing approval for Zepzelca (lurbinectedin) from the Macau Bureau of Pharmaceutical Administration for the treatment of adult patients with lung cancer. metastatic small cell carcinoma (SCLC), with disease progression during or after platinum-based chemotherapy.
The approval of lurbinectedin in Macau is mainly based on data from two clinical trials. One based on data from an open-label, multicenter, single-arm monotherapy study in 105 adult patients with recurrent metastatic small cell lung cancer (including patients with platinum-sensitive and platinum-resistant disease), which the Food and Drug Administration The US Food and Drug Administration (FDA) used to grant accelerated approval of lurbinectedin. The other, conducted in China, is a single-arm, dose-escalation, and dose-expansion clinical trial, which aimed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of lurbinectedin in Chinese patients with advanced tumors, including Recurrent SCLC.
In April 2019, PharmaMar and Luye Pharma signed an agreement for the development and commercialization of lurbinectedin in CPCP.
Currently, lurbinectedin is authorized in 14 countries around the world, in addition to Macau. Meanwhile, the application for authorization to market lurbinectedin in Hong Kong and mainland China is being studied.
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] from this cause, of which SCLC represented 13-17% [2].
Pharma Mar SA is a Spain-based integrated biopharmaceutical company focused on oncology and committed to research and development (R&D) of antitumor drugs of marine origin. The Company, through its subsidiaries, operates three business segments: Oncology, Diagnostics and RNA interference. The Oncology segment encompasses research, develop and market anti-tumor drugs. The Diagnostics segment includes the development and marketing of diagnostic kits. The RNA interference segment consist of the development of drugs with therapeutic activity based on reducing or silencing gene expression. The Companyâs product portfolio includes Yondelis and ZEPZELCA. Yondelis (trabectedin) is indicated for the treatment of advanced soft tissue sarcoma, as well as for the treatment of relapsed platinum-sensitive ovarian cancer. ZEPZELCA (lurbinectedin) is indicated for the treatment of metastatic small cell lung cancer (SCLC) with disease progression. The Company is active globally.
PHARMA MAR, S.A. 
