On the 15th December 2016, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for granting marketing authorization for TruximaTM, a rituximab biosimilar monoclonal antibody targeting CD20 in B-cells. The marketing approval application for TruximaTM was submitted by Celltrion Healthcare Hungary Kft. The CHMP concluded that TruximaTM shows “comparable quality, safety, and efficacy to Mabthera® (rituximab)” from Roche.
The CHMP gave positive opinions for using TruximaTM in combination with chemotherapy in first-line FL patients with stage III–IV disease, and for use as maintenance therapy following an induction response. TruximaTM is also indicated for use in stage III–IV FL patients resistant or who relapse following first-line chemotherapy. The CHMP positive opinion also includes an indication for use in CD20-positive DLBCL in combination with CHOP-based chemotherapy, and an indication for use in untreated and R/R CLL patients in combination with chemotherapy.
TruximaTM is proposed to be available in 500mg solutions for infusion and the data for the use of this drug is based on the previous EMA approval of Mabthera® (rituximab). The full indication for TruximaTM is listed below:
“Non-Hodgkin’s lymphoma (NHL)
Truxima is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
Truxima monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.
Truxima 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 leukemia (CLL)
Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Truxima or patients refractory to previous Truxima plus chemotherapy.”
- European Medicines Agency, Committee for Medicinal Products for Human Use. CHMP summary of positive opinion for Truxima. EMA/CHMP/813387/2016. 2016 Dec 15. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004112/WC500218017.pdf. [Accessed 17/01/17].