Japanese study group urges Zolinza appro

The development in Japan of Merck & Co's Zolinza (volinostat) for the treatment of cutaneous T-cell lymphoma (CTCL) has been urged by a study group on the use of unapproved drugs within Japan's Ministry of Health, Labor and Welfare on April 26.

Zolinza was approved as a treatment for CTCL in the USA on October 6, 2006, and was launched there later that year. However, Merck's Japanese subsidiary, Banyu Pharmaceutical, declined to conduct Phase II clinical trials for non-Hodgkin's lymphoma, including CTCL, because there are only a small number of patients with the condition in Japan. The number of such people is just 10%-20% of those in the USA and Europe. Instead, it has tried to conduct clinical studies for the treatment of non-small cell lung cancer and acute myelocytic leukemia prior to the trials for non-Hodgkin's lymphoma.

Since the usefulness of the drug for CTCL is clear based on the results of evaluations in the USA, the study group has recommended the Ministry to urge Banyu to develop Zolinza as early as possible.