Bayer Schering Pharma AG announced that the oral formulation of Fludara for low-grade non-Hodgkin's Lymphoma and mantle cell lymphoma has received marketing approval in Japan.
This new formulation provides a new avenue for simpler and easier outpatient chemotherapy to improve patients' quality of life, as well as that of their families. Bayer Schering Pharma plans to start marketing of Fludara Oral after National Healthcare Insurance price listing.
"With the approval of Fludara Oral in Japan, we are right on track to further expand our leadership position in haematological oncology," said Paolo Pucci, Head of the oncology business Unit at Bayer Schering Pharma. "The addition of Fludara Oral to our portfolio will strengthen our position in Japan, the world's second largest pharmaceutical market."
Unlike alkylating cytotoxic chemotherapies, Fludara, a purine nucleotide analog, inhibits the synthesis of new DNA, thus preventing leukaemia cells from multiplying. The intravenous formulation of Fludara was first approved in 1991 and is available in 98 countries worldwide as a second-line therapy for B-CLL patients who have failed previous treatment with alkylating agents. In addition, Fludara has been approved as a first-line therapy of B-CLL in 62 countries.
In 29 countries, Fludara is also approved for the second-line treatment of low grade non-Hodgkin's Lymphoma. The oral formulation has the same effect as the formulation and was approved in Europe in 2001.
Lymphoma is divided into two types: Hodgkin's lymphoma and Non-Hodgkin's lymphoma (NHL). NHL is a type of malignant disease that occurs within the lymphatic system. NHL is the fifth most common cancer after breast, prostate, lung, and colon cancer. It originates from lymphocytes, a type of white blood cells, which can be divided into two main types, B lymphocytes and T lymphocytes.