Novartis's Rydapt wins EU approval for AML, other diseases

Swiss drugmaker Novartis on Wednesday said it had won European Union approval for Rydapt to be used against a mutated form of acute myeloid leukemia (AML) and other rare diseases, adding to US approvals it secured in April.

Rydapt was cleared to be used along with chemotherapy to treat adults newly diagnosed with AML and carrying a specific genetic mutation called FLT3, Novartis said in a statement.

It was also approved for three types of advanced systemic mastocytosis, a rare disease where mast cells accumulate in the skin, bone marrow and some internal organs.

AML is a cancer that originates in the bone marrow and progresses rapidly, resulting in an abnormal increase in white blood cells.