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Food and Drug Administration (FDA) in May at which the agency indicated it would not consider approving Bonefos for marketing until results from the NSABP B-34 trial are known.
While we were hopeful that the existing data would be sufficient for the FDA, "said Reinhard Franzen, President and Chief Executive Officer of Berlex Laboratories, "we now look forward to the results of the NSABP B-34 trial to determine the role that Bonefos might play in the treatment of breast cancer patients.
So far, there is approximately 260,000 patient years of experience with Bonefos as a marketed product.
This new data on the ability of Bonefos to prevent metastatic bone lesions and improve survival in breast cancer patients defines a new role for application of the therapy.
Osteolysis is mediated by increased activity of osteoclasts, and Bonefos is an effective inhibitor of this activity.
The results, presented during the 5th annual European Breast Cancer Conference (EBCC), demonstrated that women treated with oral Bonefos for two years significantly reduced their chances of developing bone metastases within the first five years post-surgery.
During the two years of therapy, women being treated with Bonefos saw a decrease in bone turnover, with PINP values decreasing by 26 percent, while the placebo group had a median increase of five percent (p<0.
Women who underwent therapy with Bonefos achieved a significantly higher response (decreased bone turnover) than placebo (55 vs.
Berlex Bonefos review: FDA's Oncologic Drugs Advisory Committee will discuss Berlex' NDA (21-776) for Bonefos (clodronate) as an adjuvant treatment for the reduction of occurrence of bone metastases in Stage II/III breast cancer patients on Dec.
The court heard that Varawalla forged prescriptions for a drug called Bonefos which relieves the symptoms of bone cancer but is not available in Bombay.
com/ Bonefos = 13 hrs for IV (IV and Oral) http://www.