AbbVie and Roche are on track for approval of their chronic lymphocytic leukaemia (CLL) drug venetoclax on both sides of the Atlantic after the Committee for Medicinal Products for Human Use gave a conditional green light for the drug.
The first-in-class BCL-2 inhibitor was first launched in the US earlier this year as Venclexta for the treatment of adult CLL patients with the 17p deletion or TP53 mutation, which is seen in around 10% of all newly-diagnosed patients with this form of cancer and is a difficult-to-treat form of the disease, typically associated with poor prognosis.
In Europe, where the drug will be known as Venclyxto, it has been backed by the CHMP for adults with 17p deletion-positive CLL who are unsuitable for or have failed a B-cell receptor pathway inhibitor such as AbbVie and Johnson & Johnson’s Imbruvica (ibrutinib) or Gilead Science’s Zydelig (idelalisib), or both chemo-immunotherapy and a B-cell receptor pathway inhibitor.
The FDA approval is based on a clinical trial involving 106 previously-treated patients with 17p deletion-positive CLL who took Venclexta orally once-a-day in escalating doses. The results showed that 80% of trial participants experienced a complete or partial remission of their cancer – and prompted analysts to predict peak sales of the drug could approach $3bn.
Data from the MURANO phase III study evaluating venetoclax in a broader set of relapsed/refractory CLL patients is due next year and – if positive – would support regulatory filings for the drug in a much larger population.
It is also being tested in combination with Roche’s $7bn brand MabThera/Rituxan (rituximab), which is widely-used for CLL, as well as Imbruvica which also cleared $1.2bn in sales for last year in CLL and other haematological malignancies.
AbbVie and Roche believe that venetoclax will be effective across a range of blood cancers, and are testing the drug in acute myeloid leukemia, non-Hodgkin’s lymphoma, and multiple myeloma among others.
The partners recently started a phase III programme evaluating the BCL-2 inhibitor in combination with standard of care in multiple myeloma and have said they intend to begin phase III testing in AML before the end of 2016.