The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product MabThera ( Rituximab ).
The CHMP adopted a new indication as follows: granulomatosis with polyangiitis and microscopic polyangiitis. MabThera, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis ( Wegener’s ) ( GPA ) and Microscopic polyangiitis ( MPA ).
For information, the full indications for MabThera will be as follows:
MabThera is indicated in adults for the following indications:
MabThera is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
MabThera maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
MabThera monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.
MabThera is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP ( Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone ) chemotherapy.
Chronic lymphocytic leukaemia
MabThera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed / refractory chronic lymphocytic leukaemia ( CLL ). Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including MabThera or patients refractory to previous MabThera plus chemotherapy.
MabThera in combination with Methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs ( DMARD ) including one or more tumour necrosis factor ( TNF ) inhibitor therapies.
MabThera has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with Methotrexate.
Granulomatosis with polyangiitis, and microscopic polyangiitis
MabThera, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis ( Wegener’s ) and microscopic polyangiitis. ( Xagena )
Source: European Medicines Agency, 2013