On July 28, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Venclexta (venetoclax) in combination with low dose cytarabine (LDAC) for elderly patients with previously untreated AML who are ineligible for intensive chemotherapy (Press release, Hoffmann-La Roche, JUL 28, 2017, View Source [SID1234519919]). FDA breakthrough therapy designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious or life-threatening diseases and to help ensure that patients receive access to medicines as soon as possible. This is the seventeenth breakthrough therapy designation for Roche’s portfolio of medicines, and the fourth for Venclexta. Schedule your 30 min Free 1stOncology Demo! Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.
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Breakthrough therapy designation was granted based on data from an ongoing open-label phase Ib study of Venclexta in combination with LDAC in previously untreated elderly patients (over 65 years) with AML, an aggressive form of leukaemia, who are ineligible for intensive chemotherapy. Preliminary data from this study (M14-387) presented at the 22nd European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, 22-25 June, in Madrid 2017 (Abstract E911) showed durable efficacy with an acceptable safety profile for Venclexta in combination with LDAC in this patient group.
About AML
AML is an aggressive form of leukaemia that starts in immature forms of blood-forming cells, known as myeloid cells, found in the bone marrow.2 AML is the most common type of aggressive leukaemia in adults.1 It has one of the lowest survival rates of all types of leukaemia3. Even with the best available therapies, older patients aged 65 and over have survival rates comparable to patients with advanced lung cancer, with a five year overall survival rate of <5%.4,5 Approximately 20,000 people in the United States and 18,000 in Europe are diagnosed with AML each year.6,7
About Venclexta
Venclexta is a small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). It is believed that blocking BCL-2 may restore the signalling system that tells cells, including cancer cells, to self-destruct.
Venclexta is being co-developed by AbbVie and Roche. Together, the companies are committed to research with Venclexta, which is currently being evaluated in phase III clinical trials for the treatment of relapsed, refractory and previously untreated chronic lymphocytic leukaemia, along with studies in several other cancers including AML. Venclexta is commercialised jointly by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.