One of the world's leading innovation-driven healthcare groups, Roche, announced that the European Commission (EC) has approved the use of oral and intravenous Bondronat for the "prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases."
This indication significantly increases the number of cancer patients who can benefit from Bondronat treatment. The oral formulation is also uniquely positioned to fill an unmet patient need for a highly effective oral bisphosphonate.
"Bondronat is the only bisphosphonate to offer unsurpassed oral and i.v. efficacy and a much improved safety profile compared with currently available i.v. bisphophonates," said Dr Stefan Manth, director of Oncology at Roche. "Bondronat is also the only bisphosphonate that has demonstrated significant pain reduction from bone metastases for two years, substantially enhancing patients' quality of life," he added.
The approved dosage of Bondronat for prevention of skeletal metastases in patients with breast cancer and bone metastases is 50 mg daily administered orally at least 30 minutes before food or 6 mg administered intravenously (infusion over 1 hour) every 3 to 4 weeks.
Metastatic bone disease is the spread of cancerous cells from the original tumour to the bone and generally leads to pain and other clinical consequences, such as skeletal related events, e.g. fractures, compression of the spine, and hypercalcaemia. Bone pain is the predominant reason for patients to seek medical care.
Current therapeutic options for patients suffering from bone metastases include: chemotherapy, hormonal therapy, radiotherapy, and analgesics for pain management, surgery and the use of bisphosphonates.
Bondronat (ibandronate) is a third generation, highly potent nitrogen-containing bisphosphonate. Clinical trials with Bondronat demonstrated significant reduction in skeletal related events and significant rapid and sustained pain reduction throughout a two-year study time period. In clinical trials, Bondronat has not been associated with an increase of renal toxicity, with renal adverse event rates similar to placebo. Bondronat has been registered for several years in over 50 countries worldwide for the treatment of hypercalcaemia of malignancy with over 500'000 patients treated to date.