News Feature | January 27, 2014

Roche's MabThera (rituximab) For Non-Hodgkin Lymphoma Receives CHMP Recommendation For EU Approval

Source: Outsourced Pharma

By Estel Grace Masangkay

Roche announced that its new MabThera (rituximab) formulation for non-Hodgkin lymphoma (NHL) has received a recommendation for European Union (EU) approval from the European Union Committee for Medicinal Products for Human Use (CHMP). The positive CHMP opinion was based on results from the two-stage international phase III trial of the Sabrina study.

Roche Global Product Development Head and Chief Medical Officer Sandra Horning said, “We are excited the MabThera SC data confirm the efficacy and safety of a significantly shortened treatment time… We are confident that reducing treatment to approximately five minutes with MabThera SC will be an improvement for patients and healthcare professionals alike.”

MabThera is a therapeutic monoclonal antibody that binds to CD20 antigen found on the surface of both normal and malignant B-cells. The antibody recruits the immune system to target and attack the marked B-cells. As stem cells or B-cell progenitors in the bone marrow lack CD20 antigen, healthy B-cells are allowed to regenerate and return to normal levels within several months after treatment.

MabThera is currently delivered to patients via an intravenous infusion which takes about 2.5 hours. Roche’s new subcutaneous formulation allows delivery of 1400mg solution in about five minutes. The new SC formulation comes in a ready-to-use fixed dose, reducing pharmacy preparation time and hospital resources expenses.

NHL represents an estimated 84% of lymphoma diagnoses around the world. The disease caused over 200,000 annual deaths worldwide in 2010. Lymphoma is a cancer of the lymphatic system and interferes with the body’s production of healthy blood cells.

MabThera first received approval from the FDA in 1997 for treatment of relapsed indolent NHL. The drug received EU approval the following year. MabThera is the first targeted cancer treatment approved by the FDA. It has been approved for treatment of several blood cancers including chronic lymphocytic leukemia (CLL).

Roche expects a final decision regarding the approval of MabThera’s new formulation in the next few months, as the European Commission generally follows the CHMP opinion.

Source:

http://www.roche.com/media/media_releases/med-cor-2014-01-24.htm