FDA clears new use for Novartis drug Zometa

Novartis said that US regulators approved its recently launched drug Zometa for treating bone metastases caused by several types of cancers.

The action enables Switzerland-based Novartis to market Zometa for the new use to US doctors, and analysts say it should help boost sales of the drug, which won US approval in August for treating cancer-induced high blood calcium.

The Food and Drug Administration cleared Zometa for treating bone metastases in patients with prostate, lung or breast cancer, multiple myeloma or other solid tumors, Novartis spokeswoman Gloria Stone said.

Bone metastases, the spreading of cancer to the bone, are common and debilitating complications of prostate, breast, lung and other cancers. They can cause fractures, severe pain, spinal cord compression and excess blood calcium.

Zometa, an intravenous bisphosphonate, is important to Novartis as a successor to a similar older drug, Aredia, which faces generic competition in the United States, analysts say.

The new indication for Zometa is "an incremental positive" as Novartis seeks to add to the drug's approved uses, Mehta Partners analyst Shaojing Tong said. Tong predicted about $220 million in Zometa sales for 2002, gradually rising to a peak of about $1 billion.

The FDA based its approval on data from three clinical trials involving 3,000 patients.

Zometa can be given once every three to four weeks in a 15-minute infusion, rather than the two-hour infusion required for Aredia.

Patients should have kidney function tested before receiving each Zometa dose, Novartis said. Zometa and other bisphosphonates have been associated with declined kidney function.

The drug's most common side effects included flu-like symptoms, fatigue and gastrointestinal reactions, the company said.