Roche reported that its two anti-cancer drugs MabThera and Xeloda were approved by the European authorities for additional indications. Roche had received positive recommendation by the European authorities in mid-October last year for the innovative cancer treatments MabThera (for the treatment of aggressive Non-Hodgkin's Lymphoma) and Xeloda as well as Xeloda in combination with Taxotere (for the treatment of advanced breast cancer). This news comes just three days after the European authorities issued positive recommendations for Roche's hepatitis C treatment Pegasys and the anti-influenza drug Tamiflu, as well as a label change for the weight management treatment Xenical.
"We are excited by our continued progress in Europe. With MabThera and Xeloda we are able to bring new hope to thousands of patients. MabThera can increase the chance of cure and prolong survival for patients with aggressive Non Hodgkin's Lymphoma, a rapidly fatal form of blood cancer. Xeloda is unique with its tumor-activated mechanism and is one of Roche's most significant new products, and we believe that Xeloda can help every woman who suffers from breast cancer cancer at some stage of her disease," said William M. Burns, Head of Roche's Pharmaceuticals Division.
The authorities approved the revolutionary anti-cancer medicine MabThera (rituximab), combined with standard chemotherapy, for treating an increasingly common form of blood cancer called aggressive non-Hodgkin's lymphoma (NHL). MabThera is already indicated for low-grade NHL in Europe.
The EMEA's decision was based on results comparing MabThera plus standard chemotherapy (CHOP) with CHOP alone in a pivotal study. After analyzing the data available to date it is estimated that after two years of follow-up, 70% of patients will be alive with the MabThera plus CHOP combination, compared to 57% after standard chemotherapy alone. Current medical opinion indicates that if patients survive past the two-year milestone their chances of a cure can be up to 80%.
NHL affects approximately 1.5 million people around the world and is the 3rd fastest growing form of cancer behind melanoma of the skin and lung cancer. NHL is a more common form of blood cancer than leukaemia - approximately 55% of cases of NHL are categorised as aggressive and 45% indolent (a more slowly growing form of the disease). Until today's decision by the European authorities MabThera, Roche's second most successful product, has been indicated for relapsed or refractory indolent NHL only (low-grade NHL).
MabThera was discovered by IDEC Pharmaceuticals Corporation and was jointly developed with IDEC and Genentech, Inc. MabThera is Roche's second largest prescription product just four years after its first launch, with sales of more than CHF 1.6 billion in 2001.
The European Commission has granted marketing authorisation for Roche's anti-cancer tablet Xeloda (capecitabine) for the treatment of metastatic breast cancer. The Commission granted approval for two indications, Xeloda monotherapy after failure of intensive chemotherapy as well as combination of Xeloda with Taxotere after failure of anthracycline treatment. Xeloda/Taxotere is the first chemotherapy regimen to demonstrate a significant superior survival benefit compared to a standard treatment of Taxotere alone in patients with metastatic breast cancer, besides it showed tumour shrinkage and prevented tumour growth for longer compared with Taxotere alone.
The "smart tablet" Xeloda has a unique mechanism of action. It is activated by an enzyme, found at higher levels in cancer than in healthy tissue. This leads to more of the cancer-killing agent 5-FU being produced in the tumor, where it is needed. Taxotere further increases the levels of this enzyme, potentially leading to even more Xeloda being converted into cancer-killing 5-FU.
Breast cancer is a primary cause of cancer-related deaths in women and the third leading cause of overall mortality. Almost 384.000 patients are newly diagnosed with breast cancer in Europe annually. About 50 percent of breast cancer patients develop metastatic disease after primary treatment and the average survival time for patients after diagnosis of metastatic disease is 18 to 30 months.
Xeloda/Taxotere for the treatment of patients with metastatic breast cancer is registered in the U.S., Canada and now in the European Union. As monotherapy, Xeloda is now registered in more than 70 countries worldwide for the treatment of metastatic breast cancer. Last year Roche received marketing authorisation for Xeloda in the treatment of metastatic colorectal cancer in most countries worldwide, including the United States and Europe. Xeloda development in additional cancer indications and in combination with other cancer treatments is ongoing. Last year Xeloda achieved sales over CHF 260 million.