Bayer's oral Fludara gets MHLW approval

Bayer Schering Pharma, the health care division of Germany's Bayer AG, says that the oral formulation of its anticancer agent Fludara (fludarabine phosphate), has received Japanese marketing approval for use in the treatment of non-Hodgkin's lymphoma and mantle cell lymphoma. The company explained that the reformulated product is designed to expedite out-patient chemotherapy, and thereby improve patient quality of life.

The Berlin-based organization said that, unlike alkylating cytotoxic chemotherapies, its product, which is a purine nucleotide analog, inhibits the synthesis of new DNA, thereby preventing the replication of cancerous cells. The firm added that since the intravenous formulation of the drug was first approved in 1991 as a second line therapy for B-cell chronic lymphocytic leukemia (Marketletters passim), it has gone on to gain regulatory clearance in 98 countries worldwide, and has subsequently been accepted as a treatment for low-grade non-Hodgkin's lymphoma in a further 29 territories.

Paolo Pucci, head of the oncology business unit as Bayer Schering Pharma, said that the Japanese Ministry of Health Labor and Welfare's approval of the drug would allow the firm to consolidate its leading position in the field of hematological oncology.