Roche, AbbVie get U.S. priority review status for leukemia drug

ZURICH (Reuters) - Roche said on Tuesday that the U.S. Food and Drug Administration has granted ‘priority review’ status for its venetoclax drug for the treatment of a blood cancer, which it is developing with partner AbbVie.

Swiss drugmaker Roche's logo is seen at their headquarters in Basel, Switzerland October 22, 2015. REUTERS/Arnd Wiegmann

Analysts have said the drug has ‘blockbuster’ sales potential, meaning sales of more than $1 billion a year, and U.S. regulators had already fast-tracked it for approval last May by designating it a breakthrough therapy.

The companies have said the drug has met its primary treatment goal in patients with chronic lymphocytic leukemia who had a so-called 17p gene deletion.

The mutation has been associated with aggressive cancer and survival of less than two to three years after diagnosis.

Roche expects to win FDA approval in the first half of 2016, a spokeswoman at its Basel headquarters said.

Brokerage Cowen and Co. has predicted that venetoclax, if approved, could capture annual sales of $2 billion by 2020. It works by blocking BCL-2, a protein that is believed to prevent self-destruction of defective or cancerous cells in the body.

“Venetoclax is a potential new way to treat this difficult type of chronic lymphocytic leukemia,” Sandra Horning, Roche’s chief medical officer and head of global product development, said in a statement.

Roche will have marketing rights for venetoclax in the United States.

An AbbVie spokesman in Paris said his company will market the drug in Europe, where the European Medicines Agency has validated its marketing authorization application.

CLL is a slow-growing cancer of the blood and bone marrow and is one of the most common adult leukemias worldwide. It is generally considered incurable.

The most common serious adverse events were fever, a low red blood cell count as a result of immune response, pneumonia in 6 percent of the 107 study participants and a low white blood cell count with fever in another 5 percent.

Reporting by John Miller; Editing by Susan Fenton and Greg Mahlich