Roche’s blood cancer drug gains EU approval
pharmafile | July 29, 2014 | News story | Research and Development, Sales and Marketing | CLL, Cancer, Gilead, Janssen, Roche
The European Commission has approved Roche’s new leukaemia drug Gazyvaro (obinutuzumab) as competition for the blood cancer market heats up.
Specifically the licence is for the drug, in combination with chlorambucil chemotherapy, for patients with previously untreated chronic lymphocytic leukaemia who are too frail for intensive therapy.
“We are proud to make Gazyvaro available for CLL patients in Europe,” says Sandra Horning, Roche’s chief medical officer. “Gazyvaro is a new option that helps patients achieve deep responses to treatment that translate to longer lasting remissions.”
The European approval was based on the outcomes of the CLL11 clinical study that showed Gazyvaro, plus chlorambucil, significantly reduced the risk of disease worsening or death by 61% compared to Roche’s ageing cancer and arthritis product MabThera (rituximab) when also used with chlorambucil.
For patients in the Gazyvaro arm, median progression-free survival (PFS) was 26.7 months compared with 15.2 months for those in the MabThera arm.
Roche will now manoeuvre Gazyvaro into the market as a next-gen version of MabThera as it is set to begin losing it patents in the near future.
Gazyvaro plus chlorambucil also increased the time people with previously untreated CLL lived (known as overall survival, or OS) compared to those who received treatment with chlorambucil alone.
This is the most important endpoint for oncology products as it measures extension of life – Roche has not as yet, however, released details about how long OS was extended.
For CLL patients in Europe, Roche says it expects to begin launching Gazyvaro in a number of European countries in the coming months.
Roche is also studying Gazyvaro in other cancers of the blood where anti-CD20 antibodies have been shown to be effective, and where future combination therapies may reduce or eliminate the need for chemotherapy.
The drug, also known as Gazyva, made CHF18 million ($19.9 million) for the first half of this year, although it has only been on the US market for several months. Analysts predict, however, that Roche’s treatment will build up to CHF1.34 billion by 2018.
CLL is the most common leukaemia in Europe, representing 25-30% of all forms of the disease and each year is responsible for around 20,000 new cases and 13,000 deaths across Europe.
Growing market
This new approval from the EC comes less than a week after the European Medicines Agency recommended two other CLL treatments – Gilead’s Zydelig (idelalisib) and Janssen’s Imbruvica (ibrutinib) – both be approved on the continent.
The final decision as to whether they will enter onto the EU market is to be made by the European Commission; typically this takes around three months.
Imbruvica was also give a boost yesterday as the FDA extended its licence to treat CLL patients who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL.
The US regulator also says it is approving new labelling for the medicine to “reflect that Imbruvica’s clinical benefit in treating CLL has been verified”, after allowing it a speedy review earlier this year.
Analysts surveyed by Bloomberg expect Janssen’s treatment to be making around $3.3 billion by 2018 whilst Zydelig could eventually reach peak annual sales of around $1 billion to $2 billion.
All three treatments are already approved in the US, along with Arzerra (ofatumumab), developed by GlaxoSmithKline and Genmab, which had its cancer licence expanded in April this year to include CLL.
Ben Adams
Related Content
Gilead’s HIV treatment meets primary trial endpoint
Gilead has announced positive topline results from its phase 3 ARTISTRY-2 trial, which evaluated a …
Gilead announces first shipments of HIV prevention drug to Eswatini and Zambia
Gilead has announced the first shipments of its HIV prevention drug lenacapavir to Eswatini and …
Central nervous system cancer metastases – the evolution of diagnostics and treatment
The current forms of immunotherapy, how T cell therapy works and what the future holds
