Roche's MabThera gets nod for EU label extension

Swiss drug major Roche announced says that the European Union's Committee on Human Medical Products (CHMP) has given a positive recommendation for extension of the MabThera label to include its use in conjunction with any chemotherapy combination as first-line treatment for follicular non-Hodgkin's lymphoma, the most common form of indolent NHL. Physicians will now be able to prescribe MabThera with their preferred chemotherapy regimen as an initial treatment for their patients.

"The positive opinion is an important step forward in expanding the availability of MabThera as first-line treatment for all patients who could benefit from it," said Manfred Heinzer, head of strategic marketing oncology at Roche. "It also confirms the dramatic survival benefit to patients observed with MabThera in first-line treatment of indolent NHL and provides further hope for the future treatment of this deadly disease," he added.

The label extension is based on the results of a number of clinical trials that demonstrated the efficacy and safety of MabThera in combination with different chemotherapy regimens. The pivotal study M39021 evaluated the combination of MabThera with CVP chemotherapy (cyclophosphamide, vincristine and prednisolone) and formed the basis for the original marketing authorization in the EU for first-line treatment of follicular lymphoma in 2004. Further results from three randomized trials using MabThera in combination with several common regimens consistently demonstrated a significant improvement in overall survival when compared to the chemotherapy alone, Roche noted.