Roche is looking to expand the label in Europe on its big-selling cancer drug MabThera.

The Swiss major has submitted a marketing authorisation application to the European Medicines Agency for the use of MabThera (rituximab) as first-line treatment of chronic lymphocytic leukaemia. CLL is the most common form of adult leukaemia, accounting for approximately 25%-30% of all forms of the disease.

The filing is based on data from an 817-patient Phase III study initiated by the German CLL Study Group. An interim analysis demonstrated that treatment with MabThera in combination with the current standard chemotherapy (fludarabine and cyclophosphamide) achieved a significantly better outcome, compared to patients treated with chemotherapy alone. Full results of the study, the primary endpoint of which was progression free survival, will be presented at the American Society of Haematology meeting in San Francisco in December.

Second-quarter sales of MabThera, which is marketed in the USA as Rituxan by Roche unit Genentech and Biogen Idec, is currently indicated for non-Hodgkin’s lymphoma and rheumatoid arthritis, grew 17% to 2.87 billion francs.

Staying with Swiss firms, Basilea Pharmaceutica says that Toctino (alitretinoin), an oral therapy for severe refractory chronic hand eczema, has been recommended for regulatory approval under the European decentralised procedure.

Eleven European Union member states concluded that the profile of Toctino is favorable for the use in adults who suffer from severe CHE that is unresponsive to treatment with potent topical corticosteroids. The recommendation, which is the final step before national marketing licences are granted, means the drug will become the first authorised treatment for the disease.

Anthony Man, Basilea chief executive, noting that CHE is “a disease that heavily burdens patients' professional life and psychological well-being”, said that the recommendation is “a great moment in the history of our company".