History Of PharmaMar’s Orphan Drug Designation For PM01183 For Ovarian Cancer .

Here are the historical events for PharmaMar’s orphan drug Lurbinectedin (PM01183) for ovarian cancer :




- PharmaMar on August 20, 2012, receives FDA Orphan Drug Designation (ODD)






- On September 5, 2012, the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP), adopts a positive opinion for granting orphan drug status

- On October 1, 2012, PharmaMar presents a Poster Presentation at the 37th European Society for Medical Oncology (ESMO) Meeting held in Vienna 9/28 – 10/1/12

- On October 10, 2012, EMA grants orphan designation

- On November 7, 2012, PharmaMar presents 5 trial results for Lurbinectedin at the 24th EORTC-NCI-AACR Symposium on Molecular Targets & Cancer Therapeutics held in Dublin 11/6 -11/9/12

- On November 16, 2012, EMA publishes the public summary document of the opinion on orphan designation. Lurbinectedin (PM01183) is currently in Phase II clinical trials for ovarian, lung, pancreatic, and breast cancers.