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Amgen submits application to expand indication for Xgeva
Amgen has submitted a supplemental Biologics License Application to FDA to expand the indication for Xgeva to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases, according to a company press release.
Amgen has submitted a supplemental Biologics License Application (sBLA) to FDA to expand the indication for Xgeva (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases, according to a company press release. Xgeva currently is approved in the United States for the prevention of skeletal-related events in patients with bone metastases from solid tumors.
The sBLA submission is based on a pivotal phase 3 study ('147), which evaluated Xgeva versus placebo in 1,432 men with castrate-resistant prostate cancer. The study results demonstrated that Xgeva significantly prolonged bone metastasis-free survival by more than 4 months compared with placebo (29.5 vs 25.2 months, respectively) in men with castrate-resistant prostate cancer that had not yet spread to the bone.
Adverse events and serious adverse events were relatively similar between both the Xgeva group and the placebo group. Back pain was the most common adverse event reported in the Xgeva arm. Hypocalcemia and osteonecrosis of the jaw (ONJ) were reported with increased frequencies in patients treated with Xgeva; however the yearly rate of ONJ in the Xgeva arm was similar to prior trial results.
"The successful outcome of this study provides clinical evidence supporting the view that tumors activate the RANK Ligand pathway to penetrate bone," said Roger M. Perlmutter, MD, PhD, executive vice president of research and development at Amgen, in the press release. "Xgeva has the potential to become a significant advance for patients with castrate-resistant prostate cancer who currently have no treatment options to help prevent the spread of cancer to their bones."
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
