The US regulator cleared Venclexta (venetoclax) as a treatment for CLL patients who carry a mutation known as a 17p deletion and have been treated with at least one prior therapy after a review of just three months.
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The FDA approved this indication under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
It approved sales of Venclexta (VEHN’-clecks-tah) for patients with chronic lymphocytic leukemia who relapsed or weren’t helped by a prior treatment and are missing the part of chromosome 17 that kills cancer cells.
Patients with this genetic mutation account for an estimated 10 percent of untreated CLL patients while it encompasses about 20 percent of individuals with relapsed CLL.
The newly approved drug targets the B-cell lymphoma 2 protein, which promotes cancer growth and often is overabundant in patients with CLL, the FDA said.
“With the efficacy observed in this patient population, Venclexta has the potential to be an important and new therapy, advancing our efforts to bring novel treatment options to patients with this type of cancer”.
Venclexta is produced by AbbVie Inc. of North Chicago, Ill. In the US, about 15,000 new cases occur annually and an estimated 4,650 patients die of the disease each year. Previous year the company acquired Pharmacyclics for $21 billion, giving it control over the blood cancer drug Imbruvica.
A spokesperson for AbbVie tells me that Venclexta will cost about $109,500 for a one-year supply.
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Severe adverse events can include pneumonia, neutropenia with fever, fever, autoimmune hemolytic anemia, anemia and tumor lysis syndrome. The most common side effects of Venclexta include low white blood cell count, diarrhea, nausea, low red blood cell count, upper respiratory tract infection, low platelet count and tiredness. Venclexta also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for exclusivity to assist and encourage the development of drugs for rare diseases.
