AbbVie/Janssen win EU approval for two new Imbruvica uses

European regulators have approved AbbVie and Janssen’s Imbruvica (ibrutinib) in two expanded uses that broaden the use of the blood cancer drug.

Johnson & Johnson’s pharma unit said the European Commission approved Imbruvica in combination with Roche’s Gazxyva (obinutuzumab) as a first line drug for adults with chronic lymphocytic leukaemia.

It has also been approved in combination with Roche’s Rituxan (rituximab) for adults with the form of lymphoma known as Waldenstrom’s macroglobulinemia.

As is usually the case the decision from the EMA comes some time after identical approvals from the FDA.

The US regulator backed Imbruvica plus rituximab in Waldenstrom’s Macroglobulinemia (WM) last August, and okayed it in the new CLL combination regime in January.

Imbruvica is a Bruton’s tyrosine kinase (BTK) inhibitor – blocking these proteins decreases survival of B lymphocytes, delaying progression of certain cancers.

Imbruvica is already approved as monotherapy or in combination with other drugs in adults who have at least one prior therapy in CLL.

It is also approved in adult patients with mantle cell lymphoma who have relapsed or refractory disease.

The news comes as AstraZeneca has produced data showing its rival BTK drug Calquence (acalabrutinib) could significantly prolong progression-free survival in CLL.

Only this week Calquence got a boost from the FDA, which granted it Breakthrough Therapy designation in the US as a monotherapy for CLL.

The FDA reserves this tag for drugs that are likely to be a significant improvement over approved alternatives.

First approved by the FDA in October 2017 Calquence is some way behind in terms of sales however, bringing in $62m last year compared with the $3.6 billion generated by Imbruvica following first approval in 2013.

Imbruvica’s approval in CLL was based on results from the Phase 3 iLLUMINATE study, published in The Lancet Oncology, which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with previously untreated CLL.

In WM, the decision was based on data from the Phase 3 iNNOVATE (PCYC-1127) study, published in the New England Journal of Medicine. The study evaluated the efficacy and safety of ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.

AbbVie is in a 50/50 partnership with Janssen over Imbruvica – the former bought original development partner Pharmacyclics in 2015 for $21 billion to get access to the blood cancer drug.


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