Novartis has submitted a marketing authorisation application for Glivec (imatinib) to the European regulatory for approval in the treatment of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL), either as single agent or in combination with chemotherapy.

If approved for this new indication, Glivec would be the first therapy that specifically targets a genetic abnormality responsible for Ph+ ALL. Long-term outcomes with current drug treatment options have been poor and allogenic stem cell transplants have limited access and high risk, states a company release.

Approximately 2,500 new cases of Ph+ ALL are estimated each year in Europe and the US. Submission for US approval is planned to occur by the end of 2005.

Data for the Ph+ ALL submissions demonstrated two-year disease free survival of up to 87% and one-year overall survival of up to 84% for newly diagnosed patients taking Glivec with a standard chemotherapy regimen. Glivec targets the activity of abnormal proteins called tyrosine kinases that play important roles within certain cancer cells. Glivec inhibits the function of a tyrosine kinase known as Bcr-Abl in Ph+ ALL as well as in Ph+ CML. Bcr-Abl is the most common genetic abnormality in the adult form of ALL (also called acute lymphocytic leukaemia).

"Novartis is committed to pursing innovative regulatory submissions for Glivec that meet high unmet medical needs. This submission relies on published data generated by world leaders in the treatment of Ph+ ALL and could provide an important new treatment option in an area where standard chemotherapeutic regimens have remained essentially unchanged for a decade," said Diane Young, vice president and head of clinical development at Novartis Oncology.

First launched in 2001 and now available in more than 80 countries, Glivec is a signal transduction inhibitor approved to treat Ph+ chronic myeloid leukaemia and certain types of gastrointestinal stromal tumours (GIST). It is one of the first oncology drugs that validate rational drug design based on an understanding of how some cancer cells work.