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AbbVie, Roche get FDA OK for broader use of Venclexta

The drug is tipped to become a $2.5bn product by 2024

AbbVieA regimen based on AbbVie/Roche’s Venclexta for chronic lymphocytic leukaemia (CLL) - which has been described as ‘practice-changing’ - has been approved in the US.

The combination of Venclexta with Roche’s Rituxan (rituximab) has been approved on the strength of the phase III MURANO trial, which was a highlight at last December’s American Society of Haematology (ASH) meeting. It means that the chemotherapy-free regimen can be used in a much broader population of relapsed/refractory CLL patients, which follows a trend also seen in first-line CLL therapy.

Venclexta was approved by the FDA as a second-line therapy for CLL patients with a chromosomal abnormality known as 17p deletion in 2016, but the MURANO data means it can now also be used in patients without that mutation, both alone and in combination with Rituxan. A similar marketing application is under review by the EMA.

In MURANO, giving first-in-class BCL-2-targeting drug Venclexta (venetoclax) with anti-CD20 therapy Rituxan (rituximab: known as MabThera in Europe) reduced the risk of disease progression by 81% compared to Rituxan plus chemotherapy with Teva’s Treanda (bendamustine), the current standard therapy.

Venetoclax was associated with a greater risk of abnormally low white blood cell counts, there was no increase in severe infections or deaths related to this side effect

The trial was the first to test new a new CLL agent against standard chemo-immunotherapy and – according to investigators at ASH – suggested that Venclexta should replace chemotherapy in relapsed or refractory VCLL and that the combination with Rituxan was the preferred regimen.

Earlier this year, AbbVie’s R&D chief Michael Severino said the approval would “move us further towards our goal of establishing Venclexta as a foundational chemotherapy-free option in the CLL market”.

Venclexta is heading for sales of almost $2.5bn in 2024, according to EvaluatePharma. Roche's Genentech unit is collaborating with the company on Venclexta's development and the two firms co-market the drug in the US, with AbbVie selling it on its own elsewhere.

The two partners also have ambitions to extend the use of the drug into other haematological cancers, namely acute myeloid leukaemia (AML) and a subset of multiple myeloma patients. A marketing application in AML is due shortly.

They are also investigating its use in combination with AbbVie’s flagship cancer drug Imbruvica (ibrutinib), a BTK inhibitor also approved for CLL and other blood cancers.

Article by
Phil Taylor

11th June 2018

From: Regulatory

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