ZURICH, July 31 (Reuters) - Roche Holding AG has filed its
top-selling cancer drug MabThera for the treatment of leukaemia in the EU
following positive results from a Phase III trial, the Swiss drugmaker said on
Thursday.
The group has submitted a Marketing Authorisation Application to the
European Medicines Agency for the use of MabThera as the first-line treatment of
chronic lymphocytic leukaemia, which is the most common form of adult leukaemia.
MabThera is known as Rituxan in the United States, where it is marketed
by Genentech Inc and Biogen Idec Inc , and is Roche's
top-selling drug with sales of 2.9 billion Swiss francs ($2.77 billion) in the
first half of 2008.
The filing comes after a Pivotal Phase III study showed treatment with
MabThera, combined with the standard chemotherapy, achieved a better outcome
than when patients were treated with chemotherapy alone, the group said.
Full results of the study, which showed an increase in progression free
survival when the MabThera-based combination was used, will be presented at the
annual meeting of the America Society of Haematology in December.
Separately, Chugai <4519.T>, which is majority owned by Roche, said it
had struck a manufacturing and supply agreement for the bulk substance of
Actemra.
On Tuesday, Roche won a U.S. panel's backing for Actemra, a new
rheumatoid arthritis drug and a potential blockbuster that could help the Swiss
company diversify its business.
(Reporting by Katie Reid; Editing by Paul Bolding) ($1=1.046 Swiss Franc)
Keywords: ROCHE/
tf.TFN-Europe_newsdesk@thomson.com
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