Roche/AbbVie team scores ‘breakthrough’ FDA OK of leukemia drug

Richard Pazdur

Roche and Abbvie grabbed an accelerated approval to market their ‘breakthrough’ cancer drug venetoclax as a new treatment for patients with chronic lymphocytic leukemia who have a chromosomal abnormality called 17p deletion.

The drug will be sold as Venclexta, which targets B-cell lymphoma 2 (BCL-2) protein.

“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. “For certain patients with CLL who have not had favorable outcomes with other therapies, Venclexta may provide a new option for their specific condition.”

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A spokesperson for AbbVie tells me that Venclexta will cost about $109,500 for a one-year supply. "In determining the price of our product, we took a number of factors into account including the overall market dynamics, the benefits of the therapy to patients, the cost effectiveness of treatment and the value that the product brings to off-setting short-term and long-term costs," the company noted. 

Venetoclax had racked up three breakthrough drug designations from the FDA, which has been whisking the drug along the regulatory path with its VIP program for top cancer drugs in the pipeline. This therapy is expected to earn in the neighborhood of $2 billion a year.

For Roche and its big subsidiary Genentech, the approval marks the latest in a series of advances on the oncology front. But it’s particularly significant for AbbVie, which paid $21 billion for Pharmacyclics last year in a deal that gave it a 50% stake in the CLL drug Imbruvica. Now it’s looking at making that part of a best-in-class choice as a combo with venetoclax in CLL.

The drug makers gained an approval based on a quick, single arm study with 106 patients. About 4 out of 5 of those patients experienced a complete or partial remission of their cancer. The 17p deletion is confirmed through the use of an approved companion diagnostic, fitting neatly into Roche’s plans to concentrate on targeted therapies.

- here's the FDA release

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