In a Medscape video Ann LaCasce, associate professor of medicine and lymphoma specialist at Dana-Farber Cancer Institute in Boston, MA discussed the benefits of Venetoclax at the 2018 American Society of Hematology (ASH) annual meeting. See the link below to view the video and read the interview.
What is Venetoclax? Sold under the trade name Venclexta and Venclyxto, it is a medication used to treat chronic lymphocytic leukemia (CLL) in those who have failed first line treatment. It is used as a second line treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have shown disease progression after, or intolerance to a prior line of treatment. It was approved by the FDA in 2015, granted breakthrough therapy designation for people with CLL or SLL who have relapsed, become intolerant to or refractory to previous treatment. In 2015, the United States Food and Drug Administration (FDA) granted the breakthrough therapy designation to venetoclax for people with CLL or SLL who have relapsed, become intolerant to, or refractory to previous treatment. It is patented by U.S. pharmaceutical company AbbVie. According to Reuters Drugs to Watch, the 2020 forecast for Venetoclax sales are $1.48 billion.
Select competitive drugs include ibrutinib (about $148,000 per year) and Gilead’s idelalisib, both of which have been approved in 2014 to treat CLL. A recent cost analysis of both ibrutinib and idelalisib:
“The results are an estimated 10-year pharmaceutical cost for 100 newly diagnosed patients point that although ibrutinib and idelalisib are profound treatment advances, they will dramatically increase individual out-of-pocket and societal costs of caring for patients with CLL. These cost considerations may undermine the potential promise of these agents by limiting access and reducing adherence.”
In 2016, the FDA approved venetoclax for use in those with CLL who have 17p deletion (deletion located on the chromosome 17 short arm) and who have been treated with at least one prior therapy. Based on overall response rate, the indication was approved under accelerated FDA approval.
In October 2016 a European Medicines Agency committee recommended conditional marketing approval for venetoclax for CLL in the presence of 17p deletion or TP53 mutation; the drug had already been granted orphan status in 2012 for that use.
On June 8, 2018, the Food and Drug Administration granted regular approval to venetoclax for people with CLL or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
What does venetoclax cost? According to a master cancer drug cost list from Memorial Sloan Kettering Cancer Center, monthly costs total $8,560. According to GoodRX average Medicare copay averages from $3,200 to $5,800 for 120 tablets 100mg. In the UK this past October, NICE (National Institute for Health Care Excellence) reported that Venetoclax in combination with development partner Roche’s rituximab is not cost-effective use of NHS resources as a treatment for a kind of leukemia. See the article for more information. The UK agency does welcome further data from the MURANO trial used for approval with regulators.