Roche unit Genentech and Biogen Idec are going to have to wait a while before they can get expanded approval for their blockbuster Rituxan.
The companies say they have received a complete response letter from the US Food and Drug Administration regarding applications for Rituxan (rituximab) plus fludarabine and cyclophosphamide for the treatment of people with chronic lymphocytic leukaemia. Genentech and Biogen gave few details regarding the contents of the letter but said that the agency has not requested any new data.
The firms did note that they will continue discussions with the FDA over the drug’s final label. Rituxan, sold in Europe as MabThera, is already approved as a treatment for rheumatoid arthritis and non-Hodgkin’s lymphoma, and is a big earner.
Genentech said that sales in the third quarter grew 7% to 1.50 billion francs and a CLL approval in the USA will push that figure up further. It is already approved in Europe, in combination with chemotherapy, for use in patients with previously-untreated CLL,
New dalcetrapib trial
Meantime, Roche has announced plans at the American Heart Association meeting in Orlando to start a new Phase III study for its investigational drug dalcetrapib to evaluate how it affects atherosclerotic disease progression over 24 months.
The trial will enrol over 900 patients and principal investigator Jean-Claude Tardif, director of the research centre at the Montreal Heart Institute, said that the dal-PLAQUE 2 study “is the first of its kind evaluating both the carotid and coronary arteries using intima-media thickness and intravascular ultrasound techniques in the same patient population.”
Dalcetrapib is being developed to reduce cardiovascular events by raising ‘good’ high-density lipoprotein cholesterol. It is in the same class as Pfizer’s torcetrapib, development of which was terminated in Phase III in December 2006 due to safety concerns.
In addition, Roche stated that its dal-OUTCOMES study for dalcetrapib has enrolled more than 9,000 of its target of 15,600 patients. The trial is investigating the compound’s ability to reduce cardiovascular events “beyond and above the best standard of care
