Roche to Expand Rituxan Label - Analyst Blog

Recently, Roche and Biogen Idec (BIIB) submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for the label expansion of Rituxan (rituximab). The sBLA aims to expand the usage of Rituxan, approved for non-Hodgkin’s lymphoma, to include maintenance therapy for previously untreated patients with advanced follicular lymphoma.

 

Roche has also submitted a similar application to European Medicine Agency (EMA). The application is based on data from a phase III PRIMA study conducted with 1,217 patients. The study was meant to determine the effectiveness of Rituxan maintenance therapy following an induction treatment with Rituxan and chemotherapy on previously untreated patients with advanced follicular lymphoma. It was observed that the study met its primary end-point of an improvement in progression-free survival.

 

Rituxan is known as MabThera in Europe. The drug is co-marketed by Genentech and Biogen Idec in the US while Roche markets MabThera in the rest of the world, except Japan, where it is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

 

Roche is one of the leading players in the oncology segment. In 2009, this segment accounted for 53% of total sales. Oncology portfolio revenues rose 8% to CHF 20.7 billion, led by Avastin and other drugs such as Herceptin, MabThera/Rituxan, Tarceva and Xeloda.

 

Last month, Roche held an investor conference where it updated its future growth strategy. The company is looking to strengthen its presence in oncology and expand in other therapeutic areas such as metabolism, inflammation and central nervous system (CNS) disorder.

 

In order to further strengthen its presence in oncology, Roche is developing several new drugs such as pertuzumab and T–DM1 for HER2-positive breast cancer, RG7204 for the treatment of malignant melanoma, GA101/RG7159 for chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, and RG3616 for the treatment of advanced basal cell carcinoma and potentially other cancers such as colorectal cancer.

 

Results from these candidates are expected over the next two years, with the first regulatory submission anticipated in 2011.