Novartis gets European approval for CML drug Tasigna

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

The European Commission has approved Tasigna (nilotinib) as a treatment for Philadelphia chromosome-positive chronic myeloid leukaemia (CML) in patients resistant or intolerant to prior treatment, notably with Gleevec/Glivec (imatinib).

CML is one of the four most common types of the cancer and is responsible for about 15% of all leukaemia cases worldwide.

Taken twice-daily, Tasigna targets the production of the Bcr-Abl protein, which is produced only by cells containing the abnormal Philadelphia chromosome, which Novartis said was found to be the key driver of cancer-causing white blood cells in this condition.

The approval from the EC is based on data which showed that Tasigna produced a positive response in 49% of patients in the chronic phase of Ph+ CML and they achieved this response within three months of starting treatment.

David Epstein, chief executive of Novartis Oncology, said that the approval “gives us the opportunity to help more CML patients and, with Glivec as our first-line agent, provide comprehensive treatment options for prescribers”.

The US Food and Drug Administration approved Tasigna last month based on the same data that supported the European filing, but using a different analysis (including shorter duration of follow-up) that produced slightly different response rates, Novartis added.

Phase III trials have also been launched to explore the potential of the drug in newly-diagnosed CML patients and also those with sub-optimal response to prior treatment.

Tasigna, which will compete with Bristol-Myers Squibb’s Sprycel (dasatinib) is now approved in 37 countries and a file was submitted in Japan in July.

Analysts believe that the drug could have sales of around US $500 million.

Novartis