US drug major Schering-Plough says that its Japanese subsidiary, Schering-Plough KK, has submitted a New Drug Application to the Ministry of Health, Labor and Welfare seeking approval to market Temodal (temozolomide) Capsules for the treatment of malignant glioma.
"Temodal is an important treatment advance for this devastating disease,” stated Robert Spiegel, MD, chief medical officer and senior vice president of medical affairs at S-P Research Institute. Consequently, the MHLW will conduct a priority review of the submission, in order to satisfy an unmet medical need in Japanese patients as quickly as possible.
The NDA is based on efficacy and safety data from six studies, including a study of 32 Japanese patients and a Phase III study conducted by the European Organisation for Research and Treatment of Cancer and the National Cancer Institute of Canada, which have all shown that the agent induces longer survival in the patients when added to radiotherapy.
Data presented at this week’s European Cancer Conference from a Phase III trial illustrated that the agent, in combination with radiotherapy, significantly extended survival in patients who had their tumours surgically removed compared to radiotherapy alone (18.3 months median survival versus 14.2 months, respectively). In addition, an improvement was also demonstrated in two-year survival rates.
"Our expectations were exceeded in this study, particularly among patients who underwent complete resection followed by Temodal and radiation therapy. Median patient survival increased as much as four months in this study, which is a benefit for patients living with this devastating disease," commented lead study investigator Dr Martin van den Bent, MD, PhD.
Malignant gliomas account for around 30% of primary brain tumours, which affect around six to eight people per 100,000 worldwide. First approved in 1999 and sold as Temodar in the US, the agent is one of only a few treatment options for patients with glioblastoma multiforme - the third leading cause of cancer death in adults aged 20 to 29.
The submission moves Schering-Plough one step closer to its aim of tripling sales in the increasingly attractive Japanese market over the next five years, on growth of drugs such as Temodar and the firm's new cholesterol-lowering agent Zetia (ezetimibe) [[29/03/05b]]. Speaking in an interview with Reuters, S-P's chief executive, Fred Hassan, explained that the firm's goal is to be ranked amongst the top 25 companies in Japan by 2010.