Drug Therapy

The FDA has announced changes to the professional labels for finasteride, 5 mg (Proscar), and finasteride, 1 mg (Propecia), to expand the list of sexual adverse events reported to the FDA, as some of these events have been reported to continue after the drug is no longer being used.

The FDA's Reproductive Health Drugs Advisory Committee recently voted that the overall risk/benefit assessment supports approval of the investigational agent mirabegron for the treatment of overactive bladder.

Janssen Research & Development, LLC, recently has unblinded the phase III study of the androgen biosynthesis inhibitor abiraterone acetate (ZYTIGA) plus prednisone for the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC) who have not received chemotherapy.

Men receiving testosterone supplementation who also receive the 5-alpha-reductase inhibitor dutasteride (Avodart) do not experience a significant difference in changes in muscle mass, muscle strength, or sexual function compared with men who do not receive dutasteride, according to a recent study.

Results from three separate clinical trials further support the efficacy and tolerability of the investigational beta3-adrenoceptor agonist mirabegron for the treatment of OAB, researchers reported at the 2012 European Association of Urology annual congress in Paris.

An FDA advisory panel recommended against using the RANK ligand inhibitor denosumab (XGEVA) to delay or prevent the spread of castration-resistant prostate cancer in patients at high risk for bone metastases.

Both the phosphodiesterase-type-5 inhibitor tadalafil (Cialis) and alpha-blocker tamsulosin (Flomax) appear to significantly improve scores on the International Prostate Symptom Score (IPSS) compared with placebo in men with signs and symptoms suggestive of BPH.

Treatment with three relatively new targeted kidney cancer drugs has been linked to a slightly elevated chance of fatal side effects, according to a new analysis led by scientists at Dana-Farber Cancer Institute, Boston.

Short-term use of the cephalosporin antibiotic cefpodoxime proxetil (Vantin) for the treatment of women with uncomplicated cystitis did not meet criteria for noninferiority for achieving clinical cure compared with ciprofloxacin (Cipro, Proquin), say researchers from the University of Miami Miller School of Medicine.

Treatment with the investigational oral androgen receptor signaling inhibitor MDV3100 significantly improved overall survival in patients with advanced prostate cancer, recent phase III study results indicate.

The FDA has approved the oral kinase inhibitor axitinib (Inlyta) for the treatment of patients with advanced renal cell carcinoma after failure of one prior systemic therapy.

The 5-alpha-reductase inhibitor dutasteride (Avodart) appears to delay disease progression and the initiation of active treatment in men with low-risk, localized prostate cancer, results of a 3-year international clinical trial indicate.

Pain interference with daily functioning was significantly less in men with castrate-resistant prostate cancer who were treated with the RANK ligand inhibitor denosumab (XGEVA) compared to zoledronic acid (Zometa) as part of a multinational, double-blind, randomized trial.

In men with castration-resistant prostate cancer and symptomatic bone metastases, the investigational radiopharmaceutical radium-223 (Alpharadin) improved overall survival by 30% and time to first skeletal-related event by 39% compared with placebo.

Statin use in patients with hyperlipidemia appears to protect against urinary stone formation.

Astellas Pharma, Inc, has announced the receipt of a letter from the FDA indicating that it accepted for filing the new drug application for mirabegron (YM178) and initiated a substantive review.

The use of multiple medications is associated with increased severity of erectile dysfunction, say researchers from Kaiser Permanente Los Angeles Medical Center.

Dendreon Corp. has announced that the Centers for Medicare & Medicaid Services has updated its coverage policy to now cover the infusion costs associated with the administration of the advanced prostate cancer immunotherapy sipuleucel-T (Provenge).

Treatment with the RANK ligand inhibitor denosumab (XGEVA) is effective at delaying the development of bone metastases in men with nonmetastatic castration-resistant prostate cancer, according to a recent multicenter study.

An international research team has discovered a genetic Achilles' heel in neuroendocrine prostate cancer-a vulnerability that researchers say can be attacked by a targeted drug that is already in clinical trials to treat other types of cancers.

Eli Lilly and Co. has announced that the FDA has approved the phosphodiesterase type-5 inhibitor tadalafil (Cialis) for once-daily use for the treatment of men who have both erectile dysfunction and the signs and symptoms of BPH.

A single dose of a bisphosphonate in prostate cancer patients with bone metastases is as effective for pain relief as single-dose radiotherapy, according to a study presented at the European Multidisciplinary Cancer Congress in Stockholm, Sweden.

An investigational alpha-pharmaceutical appears to significantly prolong survival in patients with bone metastases from advanced prostate cancer, British researchers reported at the 2011 European Multidisciplinary Cancer Congress in Stockholm, Sweden.

Daniel P. Petrylak, MD, explains the role of new first- and second-line prostate cancer therapies, how they address previously unmet needs, and their associated side effects.

Astellas Pharma Inc. has announced the submission of a new drug application and market authorization application for mirabegron, a once-daily oral selective beta3-adrenoceptor agonist, to the FDA and the European Medicines Agency.

Long-term use of degarelix (Firmagon), a gonadotropin-releasing hormone therapy approved for the treatment of advanced prostate cancer in both Europe and the United States, continues to be effective and well tolerated beyond 3 years, according a recent study.

Pfizer Inc. has announced that it has prevailed in its patent infringement action against Teva Pharmaceuticals USA, Inc., in the U.S. District Court for the Eastern District of Virginia.

Radium-223 chloride, an investigational alpha-pharmaceutical, has been granted fast track designation by the FDA for the treatment of castration-resistant prostate cancer in patients with bone metastases.

Health Canada is informing health care practitioners and patients of a labeling update for the 5-alpha-reductase inhibitor finasteride (Propecia, Proscar) to add safety information regarding rare reports of breast cancer in men.

Mylan Inc. recently announced that its subsidiary, Mylan Pharmaceuticals Inc., has launched alfuzosin hydrochloride extended-release tablets, 10 mg, for signs and symptoms of BPH.