Glivec approved in European Union for CML

Glivec/GIST trieal shows drug has 'potential to be a major advance'

BASEL, Switzerland -- Novartis announced Nov. 8 that the European Commission has authorized Glivec in the European Union as an oral therapy for treating adult patients with Philadelphia chromosome (Bcr-Abl) positive chronic myeloid leukemia (CML) after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.

The approval follows a positive recommendation by the EU's Committee for Proprietary Medicinal Products (CPMP) in July .

“We are pleased to see that medical and regulatory authorities around the world are recognizing the value of Glivec in treating CML,” said David Epstein, president of Novartis Oncology. “With this approval, Glivec, which is already changing the paradigm of CML treatment for thousands of patients worldwide, brings the next wave of cancer treatment to the European Union.”

The authorization was based on Phase I and Phase II data from more than 1,000 patients participating in a global clinical trials program.

Similarly positive results from a Phase I study evaluating Glivec in the treatment of patients with advanced gastrointestinal stromal tumors (GIST) have been reported in the Oct. 27 issue of The Lancet.

The European Organization for Research and Treatment of Cancer (EORTC) Phase I study was performed in 40 advanced soft tissue sarcoma patients, of whom 36 had GISTs. It was carried out by centers in Leuven, Belgium by Dr. Allan T. van Oosterom, president of the EORTC; in London, England by Dr. Ian Judson, vice president of the EORTC Soft Tissue and Bone Sarcoma Group; and in Rotterdam, The Netherlands, by Dr. Jaap Verweij, vice president of the EORTC.

Unusual for Phase I studies, objective responses were seen in 69 percent of GIST patients. There were 27 GIST patients with tumor-related symptoms at study entry: 24 (89 percent) experienced relief of symptoms, often within one week after starting treatment.

"Our results indicate that Gleevec has substantial activity against GISTs with manageable side effects," said van Oosterom. "For patients who have historically had very few options beyond surgery, this has the potential to be a major advance."

Glivec is currently marketed in more than 35 countries, including the U.S., Brazil, Switzerland and Australia.