The US Food and Drug Administration (FDA)
has approved zoledronic acid (Zometa) for the treatment of bone complications in
patients with multiple myeloma and patients with solid tumors, in conjunction
with standard antineoplastic therapy. These solid tumors include prostate
cancer, lung cancer, and breast cancer. Prostate cancer patients should have
progressed after completing treatment with at least one hormonal therapy.
"At Novartis, we are committed to developing innovative and
practical new treatments for patients with cancer," said David Epstein,
president, Novartis Oncology. "With this approval, Zometa offers to
physicians and patients a new, broadly effective and convenient treatment for
the debilitating bone complications of cancer."
Three Large Trials
The approval of zoledronic acid is based on data from three
large international clinical investigations that evaluated more than 3,000
patients with prostate cancer, lung cancer, breast cancer, other solid tumors,
and multiple myeloma. These clinical trials demonstrated that zoledronic acid
decreases the skeletal complications in patients with multiple myeloma and with
metastases from solid tumors.
In two placebo-controlled clinical studies conducted in patients
with bone metastases from prostate cancer or from other solid tumors, the number
of patients with skeletal events decreased and the time to first
skeletal-related event increased with zoledronic acid treatment, in comparison
Unmet Clinical Need
"Advanced cancers commonly spread to bone and cause a
variety of complications that can significantly impact a patient’s day-to-day
activities," said Matthew Smith, MD, PhD, assistant professor of medicine
at Harvard Medical School and Massachusetts General Hospital, Boston.
"There’s an unmet clinical need to address these complications,
especially in patients with prostate cancer, which makes Zometa an important
addition to the current standard treatments for men with advanced prostate
Zoledronic acid and other bisphosphonates have been associated
with renal insufficiency. Patients should have serum creatinine levels assessed
prior to receiving each dose of zoledronic acid. Caution is advised when
administering zoledronic acid with other potentially nephrotoxic drugs. Doses of
the agent should not exceed 4 mg, and the duration of infusion should be no less
than 15 minutes.
Zoledronic acid was generally well tolerated, with a safety
profile similar to that of other bisphosphonates. The most commonly reported
adverse events included a flu-like syndrome (fever, arthralgias, myalgias,
skeletal pain), fatigue, gastrointestinal reactions, anemia, weakness, cough,
dyspnea, and edema. Occasionally, patients experienced electrolyte and mineral
disturbances, such as low serum phosphate, calcium, magnesium, and potassium.