Novartis Gets FDA OK For New Gleevec Applications

Swiss drug maker Novartis AG (NVS) said Thursday that it received U.S. approval to sell the drug Gleevec as a treatment for five rare types of cancer.

The drug, known as Glivec outside the U.S., was launched in 2001 for the treatment of a rare form of leukemia and later received approval for use in a rare gastric cancer.

Now, the Food and Drug Administration approved Gleevec to treat the solid tumor dermatofibrosarcoma protuberans, which begins as a hard lump found in the skin of the chest, abdomen or leg, and to treat four blood disorders.

The blood disorders are: a rapidly progressive form of leukemia characterized by the presence of the Philadelphia chromosome; myeloproliferative disorders, in which too many types of certain blood cells are made in the bone marrow; hypereosinophilic syndrome, which is characterized by the persistent overproduction of certain white blood cells; and systemic mastocytosis, which is marked by the presence of too many mast cells, a certain type of white blood cell.

Most of these conditions happen to less than one patient per 100,000 a year, according to Novartis.

The Food and Drug Administration approved all five applications at once.

Diane Young, vice president and global head of clinical development at Novartis' oncology division, told Dow Jones Newswires that the multiple filing was possible because they are based on a new approach to cancer research that looks at the way the disease is expressed, rather than its site.

"The effectiveness of Gleevec in these five diseases further underscores how cancers and diseases of different origin and location can share common pathways that often respond to the same targeted treatment," she said.

The company also submitted the five applications for approval in Europe, where it already got a go-ahead for the treatment of acute lymphoblastic leukemia and the solid tumor.

Gleevec, which had global sales of $2.2 billion last year, has proved very successful in treating the two cancers it was previously approved for.

A recent study that followed leukemia patients treated with the drug showed that 89% were still alive after five years, an extremely high rate.

Another recent study, however, has raised concerns that the drug may be toxic to the heart and can lead to heart failure in some patients.

Earlier Thursday, the company announced it revised the label of Gleevec to include the fact that some heart problems have occurred in some patients taking the cancer drug.