Farydak is used for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent (IMiD).
Novartis said multiple myeloma is a cancer of the plasma cells, a type of white blood cell present in the bone marrow, and affects about 84,000 people in Europe.
In clinical trials, Farydak combination increased progression-free survival by 7.8 months in patients who received at least two prior regimens, including bortezomib and an ImiD.
It may help in resetting important cell function in multiple myeloma via epigenetic activity
Novartis Oncology president Bruno Strigini said: "With the approval of Farydak in the European Union, we hope to address critically important treatment needs faced by the multiple myeloma community-disease progression and treatment resistance.
"This milestone, the approval of a first in its class treatment option for patients in need of new therapies, is the result of more than 13 years of dedicated research, which has helped us better understand the development of multiple myeloma."
Apart from Europe, Farydak is also approved in the US, Chile and Japan for certain patients with earlier treated multiple myeloma. Its indications however change by country.