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FDA approves Genta's Ganite for the treatment of cancer-related hypercalcemia
New Jersey | Saturday, September 20, 2003, 08:00 Hrs  [IST]

Genta Incorporated has received approval from the Food and Drug Administration (FDA) to market Ganite (gallium nitrate injection) for the treatment of cancer-related hypercalcemia that is resistant to hydration. Ganite is the first drug from the Company to receive marketing approval and will be sold exclusively by Genta's oncology sales force in the U.S. Coincident with the launch of Ganite, Genta also announced the initiation of an assistance program to facilitate patient access to Ganite treatment.

Cancer-related hypercalcemia is a life-threatening elevation of blood calcium that can occur in up to 50% of patients with advanced cancer. The disorder is usually caused by the release of factors from tumor cells, which markedly accelerate the loss of calcium from bone. Hypercalcemia is particularly common in patients with cancers of the lung, breast, head and neck, and kidney, and multiple myeloma.

"In several randomized double-blind clinical trials, Ganite has proven to be effective against hypercalcemia in patients with a variety of cancers," noted Dr. Christopher R. Chitambar, Professor of Medicine at the Medical College of Wisconsin. Dr. Chitambar, who is also an investigator for an ongoing Ganite clinical trial stated, "Ganite's increased availability now represents a promising treatment alternative for my patients."

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