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MabThera gains maintenance therapy licence

Published on 29/10/10 at 10:36am

Roche’s MabThera has been approved as a maintenance therapy for follicular lymphoma, a common type of blood cancer.

Maintenance treatment involves giving the drug before the disease progresses, and reduces the risk of relapse and the use of repeated chemotherapy, ultimately improving the lives of follicular lymphoma patients.

The approval is based on the results from the phase III PRIMA study that demonstrated that maintenance therapy with MabThera for two years in patients who responded to initial treatment with MabThera, plus chemotherapy, doubled the likelihood of as progression-free survival compared to those who did not receive maintenance therapy.

After two years of follow-up, 82% of patients who received MabThera maintenance were in remission compared to 66% of patients who did not.

Roche said the benefit of maintenance treatment was seen across all major patient groups analysed within the trial, regardless of their tumour burden, age, gender or their response to initial treatment.

Professor Gilles Salles, Centre Hospitalier Lyon Sud, France, and principal investigator for the PRIMA phase III trial, said: “The approval of MabThera maintenance therapy in the EU is a significant step that will change the way we manage this chronic disease.”

“Having access to this new treatment option will enable patients with this serious form of blood cancer to live their lives with their disease under better control.”

MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then ‘recruits’ the body's natural defences to attack and kill the marked B- cells.

Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.

MabThera (known as Rituxan outside the EU) was approved by the FDA in February for chronic lymphocytic leukaemia (CLL), the most common form of adult blood cancer.

It is also indicated for rheumatoid arthritis patients and received the NICE thumbs up back in August as a second line treatment for the autoimmune disease.

The blockbuster cancer treatment’s primary indication is for non-Hodgkin’s lymphoma and last year earned Roche $5.6 billion in revenues.

The additional indication is expected to add several hundred million Swiss francs to MabThera's franchise, according to analyst estimates from the Wall Street Journal

Ben Adams

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