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New treatment for patients resistant to cancer drug Glivec

Published on 06/12/06 at 10:14am

The first effective option for chronic myeloid leukaemia (CML) patients resistant or intolerant to prior treatment with Glivec has been launched in the UK.

Bristol-Myers Squibb's Sprycel is the first of a new generation of oral tyrosine kinase inhibitors that block leukaemia cell growth, allowing adults with certain types of leukaemia to control their disease over a sustained period of time.

Sprycel is also indicated for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) for patients resistant or intolerant to prior therapy.

The drug has been granted orphan status in Europe and received a rapid approval in the EU and US.

Although Novartis' blockbuster Glivec (imatinib) is effective in treating newly diagnosed CML, weaknesses have begun to emerge in the five years it has been on the market. It has been estimated that the two-year incidence of resistance is around 80% in blast phase CML, 40%-50% in the accelerated phase and at least 10% in the chronic phase of the illness.

Unlike Glivec, which only targets one form of the key protein Bcr-Abl responsible for the disease, Sprycel (dasatinib) targets two proteins, along with a number of other selected cancer kinases.

Glivec is still considered the gold-standard therapy for CML, but it could face losing its status if BMS develops Sprycel as a first-line treatment for the disease in the future. Glivec was the second biggest selling hospital drug in England in 2005, making £45 million - a rise of nearly 13% over the previous year.

However, although BMS is the first pharma company to launch a new generation of oral tyrosine kinase inhibitors, Novartis is not far behind. Its similar drug Tasigna for Ph+ CML has orphan status in both Europe and the US and is being fast-tracked by the FDA for approval.

Novartis is hoping that its extensive experience in the CML market will prove invaluable once Tasigna (nilotinib) comes on stream.

Charles Craddock, professor of haemato-oncology at Birmingham University and director of the Stem Cell Transplant Unit, Queen Elizabeth Hospital, Birmingham, said: "Sprycel offers a new option for patients who have developed resistance to existing treatment. These patients previously had a poor prognosis due to the lack of effective alternatives."

Prof Craddock added: "With its multi-targeted mode of action, dasatinib has demonstrated its efficacy in CML patients who are resistant or intolerant to imatinib. This, in combination with a manageable side-effect profile, represents the first significant advance in the treatment of CML in the last five years."













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