This represents first time a regulatory authority has approved a targeted drug for five disorders at one time.
Gleevec/Glivec® (imatinib mesylate) tablets have received approval in the U.S. for five additional disorders. This marks the first time a regulatory authority has simultaneously approved one targeted medicine for so many disorders, Novartis reports.
The additional indications include one solid tumor and four blood disorders. Gleevec is already in the market for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors (GIST) in the U.S.
The FDA approvals are based on data from Novartis-sponsored clinical studies and clinical data from independent medical researchers, according to the company. “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,” notes Diane Young, M.D., vp and global head of clinical development at Novartis Oncology.
Gleevec targets the activity of proteins called tyrosine kinases that appear to play important roles within some cancer cells, explains Novartis. It has been shown to inhibit the function of the tyrosine kinase Bcr-Abl in patients with certain forms of blood cancer—Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)—and the receptor tyrosine kinase Kit in Kit-positive GIST. Researchers have found Gleevec also inhibits other tyrosine kinases, including platelet-derived growth factor receptor, which seem to be activated in disease pathways that underlie a number of rare hematologic diseases as well as some solid tumors.
The new diseases for which Gleevec received approval are dermatofibrosarcoma protuberans, relapsed/refractory Ph+ ALL, certain forms of myelodysplastic/myeloproliferative diseases, hypereosinophilic syndrome/chronic eosinophilic leukemia, and aggressive systemic mastocytosis. The company is also awaiting approval for treating patients newly diagnosed with Ph+ ALL.