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TARGET DISEASE
Glioblastoma multiforme (GBM) is the most common and most aggressive form of adult brain tumor, with an annual US incidence of approximately five cases per 100,000 people. There are approximately 10,000 new cases diagnosed annually in the US (30,000 new cases annually in the world’s seven largest pharmaceuticals markets). Unlike many other solid tumors, GBMs do not metastasize, but cause symptoms and can ultimately lead to death through invasion and impairment of brain function. While not metastasizing to other parts of the body, GBMs can travel to other brain areas, and such spread, especially into normal brain tissue, means that most often complete surgical removal is impossible.
Diagnosis usually results from an analysis of symptoms arising from the tumor causing pressure on the brain or from the impairment of particular brain functions. These may include altered cognitive abilities, seizures, speech, hearing, or visual impairment, or pain. Very often such symptoms do not arise until the tumor has grown quite large, making treatment difficult. Ultimate diagnosis relies upon MRI and PET scans and tissue biopsy.
Until earlier last year, the long-standing standard of care treatment course had been surgical resection of the tumor followed by various forms of radiation therapy. This combination led to published average overall survival of approximately 53 weeks. In 2005, an oral chemotherapy agent known as temozolomide, which partially crosses the blood-brain barrier, was approved by the FDA on the basis of a study that demonstrated an increase in the average overall survival to 64 weeks. The combination of surgery, external radiation, and temozolomide is currently considered the standard of care treatment for GBM.
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