FDA Approves Expanded Indication for Medical Device to Treat a Form of Brain Cancer


Brain Anatomy of the Child: Lateral View

The U.S. Food and Drug Administration has approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer. It is given along with the chemotherapy drug temozolomide (TMZ) following standard treatments that include surgery, chemotherapy, and radiation therapy.

Nearly 23,000 Americans will be diagnosed with brain or other nervous system cancers in 2015, according to the National Cancer Institute, and more than 15,000 will die from them. GBM accounts for about 15 percent of all brain tumors, and typically occurs in adults ages 45 to 70. Patients survive less than 15 months on average following diagnosis, because the tumor tends to be highly resistant to standard treatments.

“Patients newly diagnosed with this challenging and aggressive form of brain cancer now have another treatment option available,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “While the treatment is not a cure, it can increase survival by several months.”

In the clinical study used to support the expanded indication, patients treated with the device and TMZ lived on average three months longer than those treated with the drug alone.

Optune was initially approved in 2011 to treat patients with GBM that recurred or progressed after chemotherapy. With this expanded indication, Optune can be used as part of a standard treatment for GBM before the disease progresses.

For newly diagnosed GBM, Optune is not intended to be used as a substitute for standard treatments, but rather as an adjunct therapy, and should not be used without a physician’s supervision.

Read the Full Article

Brain Cancer Warrior

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About LFCT

This is a blog about CHILDHOOD CANCER and CHILDHOOD CANCER AWARENESS Little Fighters Cancer Trust is a non-profit organisation that offers support and aid to Children with Cancer and their families. When a child is diagnosed with cancer it affects the whole family. One of the parents, usually the mother, must give up their job to care for the child and this creates financial problems for the family. In South Africa especially the majority of these families are not well-to-do; many of them are rural. A diagnosis of cancer can wipe out any family’s finances, let alone a poor family. The costs of special medications, special diets, hospital stays, transport to and from the hospital or clinic and accommodation and food costs for the mother who spends most of the time at her child’s bedside are astronomical. These are the people and problems that fall through the cracks, and these are the people that Little Fighters Cancer Trust has pledged to help in any way possible. LFCT takes a holistic approach to assisting the Children with Cancer and their Families, with the main aim to be the preservation of individual dignity and pride. Little Fighters Cancer Trust also focuses on promotion and advocacy of National Childhood Cancer Awareness in an effort to increase awareness of Early Warning Signs of Childhood Cancer. This would result in earlier diagnosis, giving the Child with Cancer more of a chance at Treatment and Survival. See "About" for more Background info

Posted on 9 October, 2015, in Blog, Research and tagged , , , , . Bookmark the permalink. Leave a comment.

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