Lyophilized pharmaceutical composition and uses of a crystallized form of lurbinectedin

A lyophilized pharmaceutical composition comprising lurbinectedin, wherein the composition is prepared by a process comprising:

• a) preparing an acidic aqueous solution comprising lurbinectedin or a protonated form thereof;
• b) washing the acidic aqueous solution comprising lurbinectedin one or more times with a pharmaceutically acceptable, water-immiscible, polar solvent followed by washing the acidic aqueous solution comprising lurbinectedin one or more times with a pharmaceutically acceptable, water-immiscible, non-polar solvent;
• c) basifying the washed acidic aqueous solution comprising lurbinectedin resulting from step (b) with a base or buffer to precipitate a crystalline form of lurbinectedin;
• and
• d) solubilizing the crystalline form of lurbinectedin and freeze drying the solubilized lurbinectedin to convert the crystalline form of lurbinectedin to an amorphous form to produce the lyophilized pharmaceutical composition.