On May 7, 2015 Roche reported that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for venetoclax (RG7601, GDC-0199/ABT-199), an investigational medicine being developed in partnership with AbbVie, for the treatment of people who have relapsed or refractory chronic lymphocytic leukemia (CLL) with a genetic abnormality known as 17p deletion (Press release, Hoffmann-La Roche , MAY 7, 2015, View Source [SID:1234503676]). Breakthrough therapy designation is designed to accelerate the development and review of medicines intended to treat serious and life-threatening diseases with evidence showing that the medicines may provide a substantial improvement over current treatment options. Schedule your 30 min Free 1stOncology Demo! "People who have relapsed or refractory CLL with a 17p deletion typically have a poor prognosis, and do not respond to many currently available treatment options," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Clinical Development. "We are pleased that the FDA has granted venetoclax Breakthrough Therapy designation and hope this regulatory pathway will help us bring venetoclax to people with this difficult-to-treat disease soon." Know more, wherever you are: About CLL and 17p deletion
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Latest on Apoptosis in Oncology, book your free 1stOncology demo here.
CLL is a slow-growing cancer of the blood and bone marrow that is generally considered incurable, and is one of the most common adult leukemias worldwide.1,2 Most cases of CLL (95 percent) start in white blood cells called B-cells.1 In certain cases of CLL, a part of chromosome 17 is lost and along with it an important gene that controls apoptosis called p53.3 The 17p deletion is found in 3 to 10 percent of previously untreated cases and approximately 30 to 50 percent of relapsed or refractory cases.4 People with 17p deletion CLL have poor results with conventional chemotherapy regimens and a median life expectancy of less than three years.5
About venetoclax
Venetoclax (RG7601, GDC-0199/ABT-199) is an investigational small molecule designed to selectively bind and inhibit Bcl-2 proteins, an important regulator of a process called programmed cell death, or apoptosis. These proteins are thought to impact how certain blood cancers form, develop and become resistant to treatment. Bcl-2 proteins are expressed at high levels in CLL, non-Hodgkin’s lymphoma (NHL) and in other cancers caused by blood cells called B-cells. Venetoclax is being developed in collaboration with AbbVie and currently being studied in Phase II and Phase III studies for CLL and in Phase I and II studies for several other blood cancers.