Roche and its partner OSI Pharmaceuticals is celebrating the news that Tarceva has been given the green light as a treatment for lung cancer in Japan.

The Japanese Ministry of Health, Labour and Welfare said that Tarceva (erlotinib) has been approved for the treatment of patients with non-resectable, recurrent and advanced non-small cell lung cancer which is aggravated following chemotherapy. The approval is based on the submission of two Phase II studies that confirmed the safety and efficacy of Tarceva in Japanese patients, along with data from the Phase III BR.21 study which showed that 31% of patients on the Roche/OSI drug were alive at one year compared to 22% in the placebo arm.

The latter study provided the basis for the approval of Tarceva in November 2004 in the USA and in the European Union in September 2005. Two months later the US Food and Drug Administration backed the drug in combination with gemcitabine for the first-line treatment of patients with metastatic pancreatic cancer in patients who have not received previous chemotherapy. A similar approval came from the agency’s EU counterparts in January 2007.

The latest approval is a huge milestone for lung cancer patients in Japan,” said Gabriel Leung, president of oncology at OSI, adding that “the Japanese authorities have recognised the proven benefits of Tarceva and have acted admirably”. The firms noted that in 2005, the number of newly-diagnosed patients with NSCLC in Japan reached 85,000.

Japan backs Novo Nordisk’s Levemir

Staying with Japan, and the JMHLW has also approved Novo Nordisk’s long-acting insulin analogue Levemir (insulin detemir),has been approved for treatment of diabetes type 1 and 2.

The Danish firm said that it plans to launch Levemir before the end of the year, noting that with this approval, Novo will be the only company in Japan “offering rapid-acting, pre-mixed as well as long-acting modern insulins”. It is estimated that diabetes currently affects more than 16 million people in Japan.

Levemir was approved in Europe in 2004 and in the USA in 2005 and is currently sold in 58 countries.