Novartis' leukemia drug Glivec® approved in Switzerland

27-Jun-2001

Novartis announced today that its Glivec®1 In the US: Gleevec1 (imatinib) drug has been granted marketing authorization by the Intercantonal Office for the Control of Medicines (IKS). Glivec, which is administered orally, is used to treat patients suffering from chronic myeloid leukemia (CML) in the blast-crisis and accelerated phases and in the chronic phase after interferon-alpha therapy has failed. Glivec will be available for prescription as early as Wednesday, 27 June 2001 and will be included on the list of reimbursable pharmaceutical specialties as of 15 July 2001.

Thomas Ebeling, CEO of Novartis Pharma AG, commented: "Glivec substantially improves the quality of life for many patients suffering from CML, and we are pleased that it will now be available for patients in Switzerland, as well as in the US. In addition, the Swiss registration provides a basis for future approval in some 80 other countries."

About CML Glivec (previously also known as 'STI571') is used in the treatment of chronic myeloid leukemia (CML). In this disease, white blood cells proliferate in an uncontrolled manner and accumulate in large numbers first in the bone marrow and then in the bloodstream. The disease occurs in three phases and, without treatment, it is generally fatal. Conventional drugs used to treat the disease lack specificity and their efficacy is limited. In addition, they are associated with adverse effects which can be very severe.

CML is one of the four most common types of leukemia. Worldwide, the disease occurs in one to two cases per 100 000 people per year and accounts for 1520% of all adult leukemias. In Switzerland, up to 100 new cases of CML are diagnosed each year, and the total number of patients affected is estimated to be around 500.

Clinical results In published Phase II clinical trials with Glivec, 88% of patients with chronic phase CML, in whom interferon had failed, achieved hematologic response; 49% acheived cytogenetic response. For patients in the accelerated phase the hematologic response rate was 63% and the cytogenetic response rate 21%. In blast crisis patients, the hematologic response rate was 26% and the cytogenetic response rate approximately 14%. The duration of response in the accelerated phase usually lasted longer than 6 months but cannot yet be estimated; in blast crisis, the response duration was approximately 6 months.

A recent article in Science demonstrates biological mechanisms that could explain the relapses (re-appearance of leukemia cells) among patients in the blast crisis stage. This understanding will direct and accelerate the development of rational strategies to address relapse and may further increase the effectiveness of Glivec in advanced stages of disease. Glivec is being tested at higher doses and in combination with other anticancer drugs.

About Glivec Glivec is the first anticancer agent to have been developed against a specific molecular target. The drug is tailored to target the protein resulting from the genetic defect found in CML patients: it blocks intracellular signals that are implicated in tumor development, thereby arresting the uncontrolled and fatal proliferation of white blood cells. Administered orally, Glivec produces considerably fewer adverse effects than existing standard interferon treatments.

Additional research Novartis has been working since last November with cancer institutes around the world that have included Glivec in clinical programs. Studies designed to determine whether Glivec is also effective in other cancer settings and to test its potential use in combination therapy.are under way. Initial results in gastrointestinal stromal tumors (GIST) have been positive. In GIST, a different gene product is rapidly and specifically inhibited in a selective way similar to that seen in CML.

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