On September 1, 2021 Immedica Pharma AB reported that the United Arab Emirates Ministry of Health and Prevention has approved ZepzelcaTM (lurbinectedin) – for the treatment of metastatic Small Cell Lung Cancer (SCLC) (Press release, Immedica Pharma, SEP 1, 2021, View Source [SID1234587088]).
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"Small cell lung cancer is a disease with limited treatment options. The approval of Zepzelca in United Arab Emirates represents an important treatment option for patients whose metastatic SCLC has progressed after traditional chemotherapy such as platinum-based therapy," said Anders Edvell, CEO at Immedica Pharma.
Immedica has a strategic alliance/partnership with Pharma Mar, the biopharma company which has successfully developed lurbinectedin. Both companies are committed to bringing innovative therapies to patients worldwide.
Ashraf Attia, Regional Director in the Middle East at Immedica said: "Today’s announcement marks a significant milestone for Immedica’ s ambition to expand our presence in oncology in the Middle East region."
The approval of Zepzelca by United Arab Emirates Ministry of Health and Prevention is based on results from an open label, multi-center, single-arm clinical trial in 105 adults with relapsed SCLC1. 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 is based on the same data.
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