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March 17, 2005

Temodar Approved for Glioblastoma Multiforme, USA

Topics: Medicine

Of the estimated 17,000 primary brain tumors diagnosed in the United States each year, approximately 60% are gliomas. Gliomas comprise a heterogeneous group of neoplasms that differ in location within the CNS, in age and sex distribution, in growth potential, in extent of invasiveness, in morphological features, in tendency for progression, and in response to treatments. Glioblastoma multiforme (GBM) is by far the most common and most malignant of the glial tumors.

The following new article on the approval of Temodar for GBM was based on efficacy and safety data from a large randomized controlled study conducted by  the EORTC in patients with "newly diagnosed" GBM.  The median survival was 14.6 months with radiotherapy plus temozolomide and 12.1 months with radiotherapy alone.

- Medical News Today

The Food and Drug Administration (FDA) has granted approval of a new indication for Temodar (temozolomide). The drug, used concurrently with radiotherapy and as maintenance therapy after radiotherapy, can extend the lives of adult patients newly diagnosed with glioblastoma multiforme (GBM), the most common form of malignant brain cancer.

GBM is usually fatal. The annual incidence of GBM is four to five cases per 100,000 persons with 8,000 to 10,000 new cases diagnosed per year in North America.

  Composed of poorly differentiated neoplastic astrocytes, glioblastomas primarily affect adults, and they are located preferentially in the cerebral hemispheres. Much less commonly, GBMs can affect the brain stem in children and the spinal cord.

Sources: Medical News Today and

Related reading:
MGMT gene silencing and benefit from temozolomide in glioblastoma.

Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma.

Efficacy and Toxicity of Postoperative Temozolomide Radiochemotherapy in Malignant Glioma.

Posted by Hyscience at March 17, 2005 1:01 PM

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