Reclast Single-Dose Infusion Approved for Paget's Disease

May 1, 2007

The advent of prostate-specific antigen (PSA) screening has increased early detection and treatment of prostate cancer. Most patients respond well to prostatectomy or localized radiation therapy if the cancer is diagnosed before it metastasizes. As a result, the mortality rate from prostate cancer has fallen significantly since the late 1980s.

ROCKVILLE, Maryland—FDA has approved Novartis' Reclast (zoledronic acid) for the treatment of Paget's disease, a bone disorder estimated to affect about 1 million people in the United States. Reclast is the first approved treatment for Paget's disease patients to be given as a single 15-minute IV infusion; current oral therapies generally are taken daily for up to 6 months.

The approval was based on data comparing a single 5-mg dose of Reclast with the current standard Actonel (risedronate sodium tablets), 30 mg/d for 60 days, in two identically designed 6-month trials. Combined results showed a 96% response rate in patients taking Reclast, compared with 74.3% in patients taking Actonel at 6 months (P < .001) (Reid et al: N Engl J Med 353:898-908, 2005).

The studies also showed that Reclast starts working faster. Patients who took Reclast had a therapeutic response after a median of 64 days vs 89 days for those taking Actonel. Overall, the number of patients with adverse events was similar in both groups. During post-study follow-up (median, 190 days), 21 of 82 Actonel patients had a loss of therapeutic response vs 1 of 113 Reclast patients (P < .001).

"The fact that Reclast is both highly effective and can last for several years in most patients could make this the new standard of care for Paget's patients," said Frederick R. Singer, MD, director of the Endocrine/Bone Disease Program at John Wayne Cancer institute, Santa Monica, California.

Zoledronic acid is also approved as Zometa Injection for the treatment of hypercalcemia of malignancy, multiple myeloma, and bone metastases of solid tumors in conjunction with standard antineoplastic therapy.