- AbbVie's blood cancer drug Venclexta won FDA approval on Monday for second-line treatment of an aggressive type of chronic lymphocytic leukemia (CLL). Roche's Genentech will co-market the drug in the U.S.
- Venclexta (venetoclax) was approved for patients with a genetic mutation known as 17p deletion and will be the first FDA-approved treatment targeting the B-cell lymphoma 2 protein.
- Forecasts have pegged Venclexta for blockbuster sales by 2020, bolstering AbbVie's presence in the CLL space. Together with Johnson & Johnson's Janssen, AbbVie co-developed Imbruvica, which recently was granted an expanded indication for first-line treatment of CLL.
In a single-arm trial of Venclexta, nearly 80% of the 106 patients experienced either a complete or partial remission of their cancer. The drug's approval will expand second-line options for patients with 17p deletion, which is a marker for aggressive, chemotherapy-resistant CLL.
The chromosomal abnormality occurs in about 10% of patients with untreated CLL, and approximately 20% of patients with relapsed CLL, according to the FDA. Although a smaller subset of the larger CLL patient population, 17p deletion is typically associated with a poor prognosis. Most patients with the mutation have a life expectancy of less than two to three years.
“These patients now have a new, targeted therapy that inhibits a protein involved in keeping tumor cells alive,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
The drug is the first approved treatment which inhibits the BCL-2 protein. This protein can hinder programmed cell death and tends to be more common in CLL cells. By inhibiting BCL-2, VenClexta helps attack the CLL cells.
“BCL-2 inhibition is a novel mechanism which brings a new treatment option to patients who need additional therapies," said Richard Gonzalez, CEO of AbbVie.
Venclexta was approved for daily use in patients with confirmed 17p deletion, as measured by a companion diagnostic manufactured by Abbott Molecular.
Thomson Reuters Cortellis projects 2020 sales of the drug to hit $1.477 billion by 2020. The drug will be jointly marketed in the U.S. by AbbVie and Roche's Genentech, and by AbbVie alone elsewhere.