'Glivec' moves closer to European approval

BASEL, Switzerland — Novartis has received a positive opinion from the Committee for Proprietary Medicinal Products (CPMP) for using Glivec (Gleevec in the U.S.) to treat people with chronic myeloid leukemia.

The European Union (EU) Commission usually grants approval of products four months after a CPMP positive opinion. Novartis’ announcement was issued July 27.

“Novartis is extremely gratified that Glivec, which has already benefited thousands of CML patients worldwide, is now one step closer to becoming readily available to patients in the European Union,” said David Epstein, president of Novartis Oncology.

Specifically, Novartis is seeking approval use Glivec on adults with chronic CML where interferon-alpha therapy has failed, and on adult CML patients in the accelerated phase or in blast crisis.

To date, Novartis has received marketing clearance for Glivec in the United States, Switzerland, Argentina, Guatemala, Jordan, Korea, Mexico, Peru and Syria.

The application was based on data from more than 1,000 patients participating in Phase I and II clinical trials worldwide.

In chronic phase CML patients who'd not responded to interferonalpha therapy, the latest data confirm near complete, durable hematologic responses in more than 90 percent of patients, with more than half achieving a complete or near complete disappearance of the Philadelphia chromosome in the bone marrow.

Patients in the accelerated phase of the disease have continued high hematologic responses, with good cytogenetic response rates. Blast crisis patients continue to have rapid hematologic blood count responses though this was sustained in less than a third of the responders.

Glivec is one of the first oncology drugs that validates rational drug design based on the understanding of how cancer cells work.

The first submissions for marketing authorization were filed only 32 months after the first dose in man. This timeline more than halved the typical drug development timeframe of approximately six years.