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AbbVie's venetoclax set for early access in UK

Drug for CLL patients included in EAMS by MHRA

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Patients with chronic lymphocytic leukaemia could be eligible for treatment with AbbVie's venetoclax under an early-access scheme.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has looked at the scientific evidence for venetoclax in CLL patients with a hard-to-treat form of the disease, and concluded the drug should be included in the Early Access to Medicines Scheme (EAMS).

Under the EAMS, experimental drugs can be given to patients before a marketing license has been granted - and in advance of a cost-effectiveness assessment by the National Institute for Health and Care Excellence (NICE). It has been used to provide early access to four medicines since starting up in 2014.

Venetoclax is being developed by AbbVie and partner Roche as a treatment for CLL patients who have 17p deletion or TP53 mutations and are unsuitable for or have failed a B-cell receptor pathway inhibitor therapy such as Johnson & Johnson's BTK inhibitor Imbruvica (ibrutinib) or Gilead Sciences' Zydelig (idelalisib).

There are around 3,000 cases of CLL each year in the UK, with 17p deletion and TP53 mutations each accounting for around 10% of the cases. If a CLL patient's cancer cells do not have 17p deletion or TP53 mutation, venetoclax can also be used after chemo-immunotherapy plus a B-cell receptor pathway inhibitor.

AbbVie and Roche's drug is a first-in-class BCL-2 inhibitor that has already been launched in the US as Venclexta for the treatment of adults with 17p-positive CLL, which accounts for around 10% of all CLL cases and is associated with a poor prognosis. It is currently under regulatory review at the EMA.

The two companies have a phase III study called MURANO evaluating Venclexta in a broader set of relapsed/refractory CLL patients that is due next year. If positive, that could support a filing for an expanded label covering all relapsed/refractory CLL patients.

Venclexta is tipped to become a big-seller for AbbVie and Roche, with some analysts expecting sales of up to $3bn at peak, providing it can also win approval in follow-up indications such as first-line CLL, combination CLL therapy with Roche's MabThera/Rituxan (rituximab), non-Hodgkin's lymphoma (NHL), acute myeloid leukaemia (AML) and multiple myeloma.

Article by
Phil Taylor

24th August 2016

From: Research, Regulatory

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