FDA updates diabetes drug label, citing increased bladder cancer riskAugust 18th 2011
The FDA has approved updated drug labels for medications containing pioglitazone (Actos), an agent used to treat type 2 diabetes. The new labels are part of an update to the agency?s ongoing safety review of pioglitazone and increased risk of bladder cancer.
Antibiotic more effective than cranberry capsules at preventing UTIsAugust 11th 2011
In premenopausal women who have repeated urinary tract infections, the antibiotic trimethoprim-sulfamethoxazole (TMP-SMX [Bactrim, Septra DS]) appears to be more effective than cranberry capsules for preventing recurrent infections, at the risk of contributing to antibiotic resistance, Dutch researchers recently reported.
Drug maker seeks new indication: prevention of bone metastasis in men with PCaJuly 14th 2011
Amgen has submitted a supplemental Biologics License Application (sBLA) to the FDA to expand the indication for its RANK ligand inhibitor denosumab (XGEVA) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases.
CMS: Medicare will cover immunotherapy for advanced PCaJuly 7th 2011
The Centers for Medicare and Medicaid Services issued a final National Coverage Decision for sipuleucel-T (Provenge), requiring Medicare contractors to cover the use of the therapy for treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
FDA: 5-alpha-reductase inhibitors may increase high-grade PCa riskJune 23rd 2011
The FDA is informing health care professionals that the "Warnings and Precautions" section of the labels for the 5-alpha-reductase inhibitor class of drugs has been revised to include new safety information about the increased risk of being diagnosed with high-grade prostate cancer, although the risk appears to be low.
Watson confirms PDE-5 inhibitor patent challengeJune 16th 2011
Watson Pharmaceuticals, Inc. recently confirmed that its subsidiary, Watson Laboratories, Inc., filed an abbreviated new drug application (ANDA) with the FDA seeking approval to market sildenafil citrate tablets in 25-, 50-, and 100-mg doses.
Investigational targeted therapy extends RCC progression-free survivalJune 9th 2011
The investigational agent axitinib (AG-013736) appears to significantly extend progression-free survival compared with sorafenib (Nexavar) in patients with previously treated advanced renal cell carcinoma, according to a study presented at the American Society of Clinical Oncology annual meeting in Chicago.
New advanced PCa agent improves castration-resistant survivalJune 9th 2011
Patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel (Taxotere) showed a significant improvement in overall survival when treated with abiraterone acetate (ZYTIGA) plus prednisone compared with patients treated with prednisone plus placebo, the authors of a phase III trial reported.
RANK ligand inhibitor increases bone metastasis-free survivalMay 26th 2011
The RANK ligand inhibitor denosumab (XGEVA) appears to significantly increase bone metastasis-free survival for more than 4 months in men with castrate-resistant metastatic prostate cancer that has not yet spread to bone, results of a multicenter study indicate.
Phase III data affirm advanced PCa agent's benefits post-chemoMay 17th 2011
Updated phase III clinical trial results provide further evidence that oral abiraterone acetate (ZYTIGA), which was recently approved by the FDA, is well tolerated and has significant clinical benefit in men failing previous intervention for metastatic castration-resistant prostate cancer, according to a multicenter study.
Advanced prostate cancer drug receives FDA approvalMay 12th 2011
The FDA has approved abiraterone acetate (ZYTIGA), an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel (Taxotere).
CMS issues favorable decision on prostate Ca immunotherapy coverageApril 14th 2011
The advanced prostate cancer autologous cellular immunotherapy sipuleucel-T (Provenge) improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer and thus is reasonable and necessary for that indication, according to a proposed decision memo from the Centers for Medicare & Medicaid Services.
Investigational OAB treatment shows promise in phase III studiesMarch 31st 2011
Mirabegron, an investigational agent for the treatment of overactive bladder, appears to improve urinary incontinence and frequency of micturition, according to data from two phase III studies presented at the 2011 European Association of Urology annual congress in Vienna, Austria.
Report shows continued high rates of inappropriate antibiotic useMarch 24th 2011
High rates of inappropriate antibiotic use persist despite a 15-year national outreach campaign by the Centers for Disease Control and Prevention to educate providers and consumers on the dangers of antibiotic overuse, according to an issue brief from the Center for Healthcare Research & Transformation, Ann Arbor, MI.
Statin use may reduce risk of high-grade prostate cancerMarch 24th 2011
Men who take statins may be 60% less likely to be diagnosed with high-grade prostate cancer, according to a study presented at the Prostate Cancer Research Program?s Innovative Minds in Prostate Cancer Today (IMPaCT) conference in Orlando, FL.
Men who take nonsteroidal anti-inflammatory drugs three times per day for more than 3 months are 2.4 times more likely to have erectile dysfunction than men who do not take the drugs regularly, say researchers from several California locations of Kaiser Permanente.
5-ARI helps slow early-stage prostate cancer growthMarch 17th 2011
The 5-alpha-reductase inhibitor dutasteride (Avodart) appears to slow the growth of early-stage prostate cancer among men undergoing active surveillance, according to data presented at the Genitourinary Cancers Symposium in Orlando, FL.