Please login to the form below

Not currently logged in

Roche wins European approval for new leukaemia drug

Gazyvaro now available for use in treatment of blood cancer in the EU
Roche Basel Switzerland

Roche's Gazyvaro (obinutuzumab) has been approved in Europe to treat the blood cancer chronic lymphocytic leukaemia (CLL).

The European Commission confirmed an earlier recommendation from regulators that backed the antibody in combination with chlorambucil chemotherapy as a first-line treatment in CLL patients who have another condition that make them unsuitable for intensive therapy will fludarabine.

The decision comes nearly nine months after Gazyvaro was approved in a similar indication in the US under the name Gazyva.

The drug is one of several new treatments for the blood cancer that have emerged in recent years. Just last week the European Medicines Agency (EMA) issued recommendations to both Janssen's Imbruvica (ibrutinib) and  Gilead's Zydelig (idelalisib) in CLL indications.

Both these drugs have also received approvals in the US this year: Imbruvica's covering CLL patients who have failed first-line therapy and Zydelig's covering three types of blood cancer, including relapsed CLL.

GlaxoSmithKline and Genmab also have a new CLL drug in the form of Arzerra (ofatumumab), which was approved in the US in April this year.

Regarding the European approval of Gazyvaro, Roche's chief medical officer Dr Sandra Horning said the drug is a “new option that helps patients achieve deep responses to treatment that translate to longer lasting remissions”.

Roche said it expects to launch the drug in a number of European countries later this year and the company also has hopes for Gazyvaro's prospects in other types of blood cancer.

Specifically, the company is researching targets where anti-CD20 antibodies have been shown to be effective, and where future combination therapies may reduce or eliminate the need for chemotherapy.

Roche's existing interests in blood cancer include MabThera/Herceptin (rituximab), which has been a big success for the company but is set to face competition from biosimilar versions due to the drug's impending patent expiry.

30th July 2014

From: Sales



Featured jobs

Subscribe to our email news alerts


Add my company
Blue Latitude Health

Blue Latitude Health is a creative marketing consultancy. Founded in 2003, our combination of heritage, approach and capability gives us...

Latest intelligence

Waking the sleeping giant
The lights are coming on for healthcare delivery in Africa...
How to get rep buy-in for multi-channel
How do you manage a team who may be resistant to change?...
Blog: Digital therapeutics: within our reach?
Digital therapeutics is a hot topic right now. By using digital technology to manage, treat or even prevent chronic conditions, digital therapeutics is promising to revolutionise healthcare. But is this...