Novartis seeks US/EU approval for Glivec

Switzerland's Novartis has filed regulatory submissions in the USA andEuropean Union for Glivec (imatinib mesylate), its new drug for the treatment of patients with chronic myeloid leukemia who are in blast crisis, accelerated-phase or chronic-phase CML, having failed first-line therapy with interferon alfa. Additional filings in Switzerland, Japan and other countries will take place shortly, according to the firm.

In the USA, the Food and Drug Administration has granted fast-track status for the drug in myeloid blast crisis-phase CML, so it could be approved within six months of its filing date (February 27). The drug has also been designated an orphan drug in the USA, EU and Japan.

Glivec has been tipped as a potential blockbuster for Novartis, and it is a measure of its importance to the firm that the drug has reached the registration stage just 32 months after first being tested in man. Beyond its initial indications in CML, where it has shown unprecedented activity in clinical trials (Marketletter December 11, 2000), Novartis believes Glivec has potential in other hematological malignancies characterized by the presence of the Philadelphia chromosome, including acute lymphocytic leukemia and acute myeloid leukemia, as well as solid tumors such as those affecting the brain and small cell lung cancer.