Xeloda combination extends breast cancer survival and becomes a new standard of care
LONDON, ENGLAND -- May 1, 2002 -- Roche announced that 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 significantly superior survival compared to a standard treatment of Taxotere alone in patients with metastatic breast cancer.
"The latest European approval for Xeloda is significant news for breast cancer patients and their families", said William M.Burns, Head of the Pharmaceutical Division and Member of the Executive Committee. "The outstanding study results have established Xeloda as a new treatment standard, and we believe that Xeloda can help every woman who battles with cancer at some stage of her disease. Xeloda is unique with its tumor-activated mechanism and is one of Roche’s most significant new products."
Xeloda Monotherapy
Xeloda monotherapy is now approved for the treatment of patients with metastatic breast cancer after failure of standard chemotherapy. Until today no cancer therapy, except Xeloda, has worked well enough to be registered for those hard-to-treat patients. The Xeloda monotherapy approval was based on data from two large multinational clinical trials.
Xeloda in Combination with Taxotere
Xeloda/Taxotere is the first and only combination chemotherapy to show a significant survival advantage in patients with metastatic breast cancer, compared to a standard treatment, Taxotere. Patients treated with Xeloda/Taxotere had a three-month survival advantage (at the median) compared to those treated with Taxotere alone. In addition to superior survival, the Xeloda/Taxotere combination also demonstrated superior tumour shrinkage and prevented tumour growth for longer compared with Taxotere alone .
Xeloda’s Unique Tumour-Activated Mechanism
The "smart tablet" Xeloda has a unique mechanism of activation. 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
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 Indications and Licensing Status
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.
Xeloda in Combination with Taxotere
Xeloda/Taxotere is the first and only combination chemotherapy to show a significant survival advantage in patients with metastatic breast cancer, compared to a standard treatment, Taxotere. Patients treated with Xeloda/Taxotere had a three-month survival advantage (at the median) compared to those treated with Taxotere alone. In addition to superior survival, the Xeloda/Taxotere combination also demonstrated superior tumour shrinkage and prevented tumour growth for longer compared with Taxotere alone .
Xeloda’s Unique Tumour-Activated Mechanism
The "smart tablet" Xeloda has a unique mechanism of activation. 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
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 Indications and Licensing Status
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.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche’s innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people’s well-being and quality of life.
Roche is the world leader in oncology. Its franchise includes Xeloda (colorectal cancer, breast cancer), Herceptin (breast cancer), MabThera (non-Hodgkin’s lymphoma), NeoRecormon (anaemia in various cancer settings), Roferon-A (leukaemia, Kaposi’s sarcoma, malignant melanoma, renal cell carcinoma), Neupogen (neutropenia) and Kytril (chemotherapy and radiotherapy-induced nausea).
Blum JL et al. Multicenter Phase II Study of Capecitabine in Paclitaxel-Refractory Metastatic Breast Cancer. J Clin Oncol 1999;17:485-93
Blum JL et al. Multicenter, Phase II Study of Capecitabine in Taxane-Pretreated Metastatic Breast Cancer. Cancer 2001,92/7:1759-68
Leonard, R et al. Survival Update of SO14999 A Large Phase III Trial of Capecitabine/Docetaxel Combination Therapy Vs Docetaxel Monotherapy in Patients with Locally Advanced (LABC) or Metastatic Breast Cancer (MBC) Eur J Cancer 2001; 37 (Suppl.6); S151; 551a World Health Organisation, 2000
Contact: Sarah Cornhill
sarah.cornill@shirehealthlondon.uk
44-207-313-6300
SOURCE: Shire
