Roche, AbbVie's venetoclax gains FDA breakthrough therapy status for chronic lymphocytic leukaemia

Roche said Thursday that the FDA granted breakthrough therapy designation to venetoclax for the treatment of people who have relapsed or refractory chronic lymphocytic leukaemia (CLL) with a 17p deletion. The drug, which is being developed in partnership with AbbVie, is designed to selectively bind and inhibit Bcl-2 proteins.

"People who have relapsed or refractory CLL with a 17p deletion typically have a poor prognosis, and do not respond to many currently available treatment options," remarked Sandra Horning, Roche's chief medical officer. The Swiss drugmaker indicated that the 17p deletion is found in 3 percent to 10 percent of previously untreated CLL cases and approximately 30 percent to 50 percent of relapsed or refractory cases.

Venetoclax is currently being studied in Phase II and III studies for CLL, as well as Phase I and II trials for several other blood cancers.

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