Novartis announced that its Japanese affiliate has filed an application with health authorities in Japan for marketing approval of Glivec (imatinib) for the treatment of patients with gastrointestinal stromal tumours (GISTs), a life-threatening cancer. This filing is based on clinical data from studies conducted in Japan and Western countries, such as the United States and member states of the European Union where Glivec is already approved for this indication.
GISTs are very difficult to treat and there are very few options beyond surgery for these patients," said David Epstein, President Novartis Oncology. "We will work closely with the Japanese authorities to facilitate the review and to make Glivec available to appropriate GIST patients in Japan as quickly as possible."
GISTs are the most common malignant form of sarcoma found in the gastrointestinal tract. Worldwide, there are approximately 12 000 new cases each year. The incidence is highest in people 30-60 years of age. Historically, GISTs have been very difficult to treat due to their resistance to available chemotherapy and radiation therapy. For patients with metastatic or unresectable disease, GISTs were an incurable malignancy with a median survival of 20 months and, with local recurrence, a median survival of 9-12 months. Until now, surgery has been the only treatment option, resulting essentially in palliation of the disease.
Glivec is approved in the EU, US, and more than 45 other countries for the treatment of patients with Kit (CD 117)-positive unresectable (inoperable) and/or metastatic malignant GISTs.
Glivec is also indicated for treatment of adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the EU, US and Japan and a number of other markets. Marketing approval in the EU, Switzerland and other countries includes the treatment of pediatric patients. In addition, Glivec is already approved in over 80 countries for the treatment of adult patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
The Japanese trials in patients with GIST confirmed the safety profile previously found in trials from other countries. The most common undesirable effects experienced during Glivec treatment in CML and GIST are: headache, nausea, vomiting, diarrhoea, dyspepsia, myalgia, muscle spasm and cramps, joint swelling, dermatitis, eczema, rash, oedema, fluid retention, neutropenia, thrombocytopenia or anaemia. Glivec is contraindicated in patients with known hypersensitivity to imatinib or any of its excipients. Women of childbearing potential should be advised to avoid becoming pregnant while taking Glivec.