On January 24, 2019 PharmaMar (PHM:MSE) reported 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 (Press release, PharmaMar, JAN 24, 2019, View Source [SID1234532892]).

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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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