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Acute Myeloid Leukaemia: Update Bulletin #3 [October 2018]

Product Code:
Publication Date:
October 2018

This edition presents the views and insights from three of the world’s foremost key opinion leaders (KOLs) from North America and Europe on a variety of recent events in the acute myeloid leukaemia (AML) market. KOLs provided their candid insights on three key events, including; AbbVie and Roche announcing that they have submitted a filing with the FDA seeking to expand the indication for Venclexta (venetoclax) to include combination use with a hypomethylating agent or low-dose cytarabine (LDAC) for patients with previously untreated AML who are ineligible for intensive chemotherapy; Otsuka Pharmaceuticals announcing that their next-generation hypomethylating drug guadecitabine (SGI-110), failed to meet the co-primary endpoints of the ASTRAL-1 Phase III study in 815 previously untreated adults with AML who are ineligible for intensive induction chemotherapy; and Jazz Pharmaceuticals announcing that Vyxeos (CPX-351) was approved by the European Commission (EC) for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Business Questions:

• Do KOLs view venetoclax in combination with a HMA or LDAC, as a potential ‘game changer’ in the treatment of elderly, non-intensively treated patients with AML?
• Is venetoclax being used off-label in the treatment of AML?
• How impressed are KOLs about the efficacy data for venetoclax in combination with a HMA or LDAC in elderly, non-intensively treated patients with AML?
• Do KOLs have any concerns over the safety of venetoclax, including the threat of tumour lysis syndrome?
• Subject to the regimen’s approval, where will venetoclax in combination with a HMA or LDAC be used in the treatment of elderly patients with AML, and which treatments will it compete with?
• Do KOLs believe that guadecitabine will be approved as a first-line treatment for AML following the results of the ASTRAL-1 trial?
• In light of the results from the ASTRAL-1 trial, do KOLs believe that guadecitabine will be successful in the relapsed/refractory AML treatment setting?
• What impact will azacitidine and decitabine generics have on guadecitabine adoption?
• Do European KOLs welcome the approval of Vyxeos, and what experience do US KOLs report for the treatment?
• How do KOLs view the efficacy and safety data for Vyxeos compared to standard treatments for AML, and are there are any data gaps that need filling?
• What additional clinical data do KOLs need to see in order to be able to predict the future usage of Vyxeos in the AML treatment paradigm?


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