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Roche reports positive data from CLL drug trial
Roche has announced positive findings from CLL11, a phase III clinical trial assessing the benefits of an investigational therapy for the common blood cancer chronic lymphocytic leukaemia (CLL).
Data from the study showed that a combination of the new compound GA101 and the standard chemotherapy chlorambucil more than doubled the length of time during which the disease did not get worse, compared to chlorambucil.
GA101 has already been awarded a breakthrough therapy designation by the US Food and Drug Administration (FDA) due to the potentially groundbreaking benefits it offers in the treatment of this deadly condition.
Marketing applications for the drug have been submitted to several regulatory authorities, including the FDA and the European Medicines Agency.
Dr Sandra Horning, global head of haematology/oncology clinical development at Roche, said: "As a former practicing haematologist, I believe GA101 has the potential to one day expand treatment options for people with CLL."
Earlier this month, the company received a recommendation from Europe's Committee for Medicinal Products for Human Use for approval of the new skin cancer drug Erivedge.
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