PharmaMar announces the approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer in the United Arab Emirates

This approval is based on overall response rate and duration of response, demonstrated in the open-label, monotherapy clinical trial. Approval represents an important advance for adult patients with Small Cell Lung Cancer (SCLC) that have progressed after platinum-based chemotherapy. PharmaMar (MSE:PHM) has announced today that its licensing partner, Immedica Pharma AB (Immedica) has received marketing approval for Zepzelca® (lurbinectedin) by the Ministry of Health and Prevention of the United Arab Emirates (UAE) for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression after platinum-based chemotherapy. The approval of lurbinectedin by UAE Ministry of Health and Prevention is based on results from the open label, multi-center, single-arm clinical trial in 105 adults with relapsed SCLC. The data, which appeared in The Lancet Oncology, in the May 2020 issue, showed that in relapsed SCLC, monotherapy with lurbinectedin had an overall response rate of 35% and a median duration of response of 5.3 months according to investigator assessments. The FDA approval was based on the same data. This approval will allow Immedica to make lurbinectedin commercially available in the UAE in the following months. PharmaMar has a strategic alliance/partnership with Immedica, both companies are committed to bringing innovative therapies to patients worldwide. “This is the second authorization of lurbinectedin from a regulatory agency, which will provide relapsed SCLC patients with a new treatment option in UAE,” said Luis Mora, Managing Director of the PharmaMar’s Oncology & Virology Business Units. Anders Edvell, CEO at Immedica Pharma, said: “Small cell lung cancer is a disease with limited treatment options. The approval of lurbinectedin in United Arab Emirates represents an important treatment option for patients whose metastatic SCLC has progressed after traditional chemotherapy such as platinum-based therapy”

The release as fetched from its publisher. pharmamar.com ↗