FDA grants AbbVie, Roche's venetoclax breakthrough therapy status in combination with Rituxan

The FDA granted AbbVie's venetoclax breakthrough therapy status in combination with Roche's Rituxan (rituximab) for the treatment of patients with relapsed/refractory chronic lymphocytic leukaemia (R/R CLL), the companies announced Wednesday. Venetoclax, which is designed to selectively bind and inhibit BCL-2, is being developed in collaboration with Roche's Genentech unit.

Roche noted that the breakthrough therapy designation for venetoclax was supported by data from the M13-365 study, which were unveiled at the American Society of Hematology annual meeting last month. The therapy was awarded priority review designation by the FDA earlier this month for use in patients with CLL, including those with p17 deletion, who received at least one prior therapy. Previously, venetoclax was granted breakthrough therapy status for the treatment of patients with R/R CLL who carry the p17 deletion.

AbbVie chief scientific officer Michael Severino said "this second breakthrough therapy designation for venetoclax granted by the FDA underscores the significant potential of this therapy in treating [R/R CLL] patients.

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