AbbVie/Roche’s Venclexta approved for CLL

AbbVie/Roche’s Venclexta (venetoclax) daily pill has been approved in the US for chronic lymphocytic leukaemia, a key drug for AbbVie and one of several potential blockbuster drugs due to hit the market this year.

Venclexta, co-developed by AbbVie and Roche’s Genentech unit, has been approved in second line for patients who have a 17p deletion detected in an approved test.

The FDA has granted an accelerated approval and continued approval depends upon verification and description of clinical benefit in a confirmatory trial.

Thomson Reuters in a report on blockbusters poised to hit the market in 2016, forecast sales of Venclexta would be almost $1.5 billion by 2020, while others have said the figure may be as high as $2 billion.

Venclexta is also important to AbbVie as the company hopes to combine it with its already approved Imbruvica (ibrutinib), another blood cancer drug it shares with Johnson & Johnson.

AbbVie is also looking for big-sellers as its Humira (adalimumab) for inflammatory diseases, currently the top selling drug in the world, will likely face biosimilar competition in the coming years.

Venclexta is a first-in-class drug that selectively inhibits the BCL-2 protein. The BCL-2 protein blocks apoptosis (programmed cell death) of cells, including some cancer cells, and can be overexpressed in CLL cells.

It is co-marketed by the companies in the US and by AbbVie outside the US.

The FDA has granted a priority review for Venclexta as a single agent. The FDA has designated it a Breakthrough Therapy in three indications, meaning it will expedite its development and review as it treats a serious or life threatening disease or condition and may provide a substantial improvement on existing therapies.

The first is the single therapy in second line for CLL with the 17p deletion indication, the second is in combination with Roche’s MabThera (rituximab) in relapsed or refractory chronic lymphocytic leukaemia and the third for untreated patients with acute myeloid leukaemia who are ineligible for standard induction therapy (high dose chemotherapy).

The European Medicines Agency (EMA) is reviewing venetoclax for patients with CLL with 17p deletion or TP53 mutation.

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