PharmaMar (PHM:MSE) announces that the Committee for Orphan Medicinal Products (COMP), from the EMA, has given its positive opinion for the approval of Orphan Drug status to Zepsyre® (lurbinectedin) for the treatment of small-cell lung cancer.
Madrid, 24 of January, 2019. PharmaMar (PHM:MSE) announces that the Committee for Orphan Medicinal Products (COMP), from the EMA, has given its positive opinion for the approval of Orphan Drug status to Zepsyre® (lurbinectedin) for the treatment of small-cell lung cancer.
Small-cell lung cancer is PharmaMar’s current priority research area. Zepsyre® (lurbinectedin) is at the Phase III investigational stage, with its ATLANTIS study for the treatment of this type of tumour. PharmaMar finalised recruitment in July 2018, and hopes to have the final data on overall survival during the second half of 2019.
PharmaMar expects to release the Zepsyre® (lurbinectedin) Phase II monotherapy data for relapsed small-cell lung cancer in the first half of 2019 and to submit it for presentation it at a future medical meeting.
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About PharmaMar
Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.
PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and a chemical enterprise, Zelnova Zeltia. To learn more about PharmaMar, please visit us at www.pharmamar.com.
About lurbinectedin
Lurbinectedin (PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.
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