AbbVie has been given a green light from the EMA for their chronic lymphocytic leukaemia (CLL) drug venetoclax, the first BCL-2 inhibitor to be approved in the EU.
The drug will be sold as Venclyxto in Europe and has been given a conditional approval for the treatment of adult CLL patents who have 17p deletion or TP53 mutation and have either failed chemoimmunotherapy or are unsuitable for treatment with a B-cell receptor pathway inhibitor such as AbbVie and Johnson & Johnson's Imbruvica (ibrutinib) or Gilead Science's Zydelig (idelalisib). It can also be used to treat CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
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.
The conditional approval comes on the back of two phase II trials, which found a 79% over response rate ORR) in previously-treated patients and a 64% ORR in patients who had been previously treated with and failed ibrutinib or idelalisib.
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.
Venetoclax was first launched in the US earlier this year as Venclexta, and is also approved in Argentina, Puerto Rico and Canada. It is predicted to become a blockbuster by 2020, with Credit Suisse suggesting sales in the year will reach $1.16bn.
Around two-thirds of that total will from CLL and a third from follow-up indications such as non-Hodgkin lymphoma (NHL) and acute myeloid leukaemia (AML), say the analysts.
Venetoclax is being developed by AbbVie and Roche, and is sold jointly by the companies in the US and by AbbVie alone elsewhere.