Novartis has been given the green light by US regulators to market its new cancer drug Tasigna for certain patients suffering from a life-threatening form of leukaemia.

The US Food and Drug Administration has approved Tasigna (nilotinib) as a treatment for Philadelphia chromosome-positive chronic myeloid leukaemia in patients who are resistant or intolerant to prior treatment, notably with the Swiss firm’s blockbuster Gleevec/Glivec (imatinib). CML is one of the four most common types of leukaemia and affects around 4,500 people in the USA each year.

Taken twice-daily, Tasigna targets the production of the Bcr-Abl protein, which is produced only by cells containing the abnormal Philadelphia chromosome, which has been found to be the key driver of cancer-causing white blood cells in this condition. The thumbs-up from the FDA is based on data which showed that at six months follow-up, the drug reduced or eliminated cells carrying the aforementioned chromosome in 40% of 232 chronic phase patients.

"Tasigna represents an important advance for the small number of patients who are resistant or intolerant to prior therapy," said David Epstein, president and chief executive of Novartis Oncology, adding that “this approval means we can offer physicians a comprehensive treatment approach with effective medicines to treat their Ph+ CML patients”. The firm noted that it will make the drug available throughout the USA “within days”.

Tasigna is already available in Switzerland European Union approval is expected by the end of the year after the Committee for Medicinal Products for Human Use issued a positive opinion in September. It was also submitted for approval in Japan in June and analysts believe that the drug could have sales of around $500 million.

Novartis to spend $700 million on Singapore biologics plant

Meantime, Novartis has announced plans to build a $700 million biotechnology manufacturing facility in Singapore, a move which represents its biggest-ever investment of this type.

Some 300 jobs will be created at the plant, which will manufacture monoclonal antibodies used in treatments for rheumatoid arthritis, cancer, asthma and spinal cord injuries, Novartis stated, adding that the site will start operations in 2012. Explaining the rationale behind the deal, the firm’s head of global technical operations Tom van Laar said that the attraction of Singapore lies in its “increasingly strong biomedical cluster and its proximity to growth markets in Asia”. Other firms that have pledged to manufacture biologics there are Abbott Laboratories, Lonza, GlaxoSmithKline and Genentech.

The announcement was made at the opening of Novartis' $180 million tablet-manufacturing plant in Singapore, which should be fully operational by 2009.