FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes

Basel, 21 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Venclexta ® (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the rev ised International Prognostic Scoring System (IPSS-R). MDS are a rare group of blood cancers that gradually affect the ability of the bone marrow to produce normal blood cells.2 This can lead to weakness, frequent infections, anaemia and debilitating fatigue.3 In some cases, MDS can also progress into acute myeloid leukaemia (AML).4,5 Every year in the US, approximately 10,000 people are diagnosed with MDS, and the median survival for those with higher-risk MDS is approximately 18 months.1,3“Higher-risk MDS is associated with poor prognosis, reduced quality of life, and limited treatment options,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased that the FDA has granted Venclexta its sixth Breakthrough Therap y Designation in recognition of its potential to improve outcomes for people with MDS in combination with azacitidine.”This designation was granted based on interim results from the phase Ib M15-531 study investigating Venclexta/Venclyxto plus azacitidine in people with previously untreated, higher-risk MDS. BT...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news