Disclosed herein is a pharmaceutical composition for oral administration comprising 4-amino-5-fluoro-3-[6-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl]-1H-quinolin-2-one monolactate monohydrate a filler, such as microcrystalline cellulose or mannitol, in an amount of 15 to 70% by weight a disintegrant, such as crospovidone, in an amount of less than 15% by weight a glidant, such as silicon dioxide, and/or a lubricant, such as magnesium stearate, in an amount of 0.1 to 10% by weight wherein the amounts by weight are based on the total weight of the composition.
