FDA grants breakthrough designation for Venclexta in combination with azacitidine
Roche announced that Venclexta in combination with azacitidine has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes based on the revised International Prognostic Scoring System . MDS are a rare group of blood cancers that gradually affect the ability of the bone marrow to produce normal blood cells. This can lead to weakness, frequent infections, anaemia and debilitating fatigue.