EMA Likes Rituximab Biosimilar, Other Cancer Drugs

Nick Mulcahy

December 16, 2016

The European Medicines Agency (EMA) has recommended granting marketing authorization to a rituximab biosimilar (Truxima, Celltrion Healthcare) for the treatment of hematologic cancers.

The recommendations come from EMA's Committee for Medicinal Products for Human Use and are for use of the rituximab biosimilar in non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

The biosimilar product is "highly similar" to the reference product rituximab (Mabthera, Genentech/Roche), according to EMA press materials. Studies indicate that the biosimilar has quality, safety, and efficacy similar to those of rituximab, which was first authorized in Europe in 1998.

Rituximab has been a top-selling oncology drug worldwide. For example, it had nearly $8 billion in sales in 2013, when it was the best-selling oncology drug globally.

The rituximab biosimilar will be available as a 500-mg concentrate for solution for infusion.

In NHL, the indications for the biosimilar include use as a treatment of previously untreated patients with stage III or IV follicular lymphoma in combination with chemotherapy; maintenance therapy for patients with follicular lymphoma responding to induction therapy; monotherapy for treatment of patients with stage III or IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy; and treatment of patients with CD20-positive diffuse large B cell lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.

In CLL, the biosimilar is indicated, in combination with chemotherapy, for the treatment of patients with previously untreated and relapsed/refractory disease.

The biosimilar also received a positive opinion from the CHMP for the treatment of nonrheumatoid arthritis and granulomatosis with polyangiitis and microscopic polyangiitis.

Also Alectinib and Chlormethine

In terms of oncology-related decisions, the CHMP also recommended granting a conditional marketing authorization for alectinib (Alecensa, Roche) for the treatment of anaplastic lymphoma kinase–positive advanced non-small cell lung cancer previously treated with crizotinib (Xalkori, Pfizer).

One hybrid medicine, chlormethine (Ledaga, Actelion), received a positive opinion for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma, a rare but life-threatening cancer. Hybrid applications are based on data from preclinical tests and clinical trials for a reference product as well as on new data.

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