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June 12, 2018

FDA approves AbbVie’s Venclexta for chronic lymphocytic leukaemia

The US Food and Drug Administration (FDA) has granted priority review approval for the use of AbbVie’s Venclexta (venetoclax tablets) in conjunction with rituximab to treat chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

The US Food and Drug Administration (FDA) has granted priority review approval for the use of AbbVie’s Venclexta (venetoclax tablets) in conjunction with rituximab to treat chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

The indication covers the oral combination as a fixed dose treatment for patients with or without 17p deletion but received at least one previous therapy.

Being developed by AbbVie in alliance with Roche, Venclexta is a BCL-2 inhibitor formulated to target the BCL-2 protein in order to restore apoptosis.

AbbVie chief scientific officer and R&D executive vice-president Michael Severino said: “Venclexta now gives indicated patients a new opportunity to significantly reduce the risk of their disease progressing, compared to a current standard of care.

“This combination provides previously treated CLL or SLL patients with a chemotherapy-free, fixed duration treatment.”

“This combination provides previously treated CLL or SLL patients with a chemotherapy-free, fixed duration treatment, allowing patients the ability to stop treatment after approximately two years.”

The FDA decision comes after reviewing the data from the Phase III MURANO clinical trial where treatment with Venclexta and rituximab led to significant improvement in progression-free survival (PFS).

Involving 389 subjects with relapsed/refractory CLL, the trial compared the investigational combination with a standard of care chemoimmunotherapy regimen of bendamustine and rituximab.

Results further revealed an 81% decrease in risk of disease progression or death and 92% overall response rate (ORR) with Venclexta and rituximab.

Venclexta has also secured approval from the FDA for its use as monotherapy to treat CLL patients with or without 17p deletion and underwent one prior therapy, while it was previously available only for people with 17p deletion.

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