Novartis completes submissions in United States, Europe for Gleevec as cancer treatment

By E. Janene Geiss

Philadelphia, April 10 - Novartis said Monday that it has submitted applications in the United States and Europe for Gleevec (imatinib mesylate) tablets as treatment for four rare types of cancer.

These filings underscore how cancers of different origin and location can share common pathways that respond to the same targeted treatment, according to a company news release.

"Thanks to the success of targeted therapies like Gleevec, these filings speak to the fundamental shift that we are seeing in the approach to cancer treatments," Diane Young, vice president and global head of clinical development at Novartis Oncology, said in the release.

Gleevec targets the activity of proteins called tyrosine kinases that play important roles within some cancer cells. Gleevec has been shown to inhibit the function of the tyrosine kinase Bcr-Abl in Philadelphia-chromosome positive (Ph+) chronic myeloid leukemia, and the receptor tyrosine kinase Kit in Kit (CD117)-positive gastrointestinal stromal tumors, officials said.

Researchers have found that Gleevec also inhibits other receptor tyrosine kinases, including platelet-derived growth factor, which have been shown to be activated in disease pathways that underlie a number of rare hematologic diseases, as well as some solid tumors, officials said.

The diseases found to have Gleevec-sensitive pathways include the solid tumor dermatofibrosarcoma protuberans, a type of tumor that begins as a hard lump found in the skin of the chest, abdomen or leg.

Three hematologic diseases were also found, including certain forms of myeloproliferative disorders, diseases 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 the white blood cells eosinophils; and systemic mastocytosis, which is marked by the presence of too many mast cells, a certain type of white blood cell.

These diseases are rare but may be life threatening, officials said. For many of the patients who suffer from them, no approved treatment is available.

Novartis said it submitted the marketing applications in Europe and the United States for dermatofibrosarcoma protuberans and myeloproliferative disorders in 2005, and for systemic mastocytosis and hypereosinophilic syndrome in 2006.

The submissions are based on a Novartis-sponsored clinical study and clinical data from trials done by independent medical researchers and cooperative trial groups demonstrating efficacy and safety of Gleevec in the treatment of these different rare diseases, the company said.

Novartis Pharmaceuticals Corp., based in East Hanover, N.J., is an affiliate of Basel, Switzerland, health care company Novartis AG.

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