Drug Therapy

GlaxoSmithKline has announced that in order to provide an update to the application, the company is withdrawing its supplemental new drug application for dutasteride (Avodart) for prostate cancer risk reduction among men at increased risk of developing the disease.

Intravesical valrubicin (Valstar) provides an effective and tolerable alternative to cystectomy for some heavily pretreated patients with carcinoma in situ that is refractory to bacillus Calmette-Guerin, according to a University of Chicago study.

Degarelix (Firmagon) is as effective as leuprolide (Lupron Depot) in reducing and sustaining castrate levels of testosterone, but during the first year of treatment, patients receiving degarelix have a significantly lower risk of PSA progression or death than those receiving leuprolide, according to a study presented at the Society of Urologic Oncology annual meeting in Bethesda, MD.

The FDA recently provided written acknowledgement that Dendreon Corp.?s amended biologics license application for sipuleucel-T (Provenge) is a complete response.

Early results with tanezumab (RN624), an investigational monclonal antibody against nerve growth factor, show promise for chronic bladder pain in interstitial cystitis.

A drug that is commonly used to treat lung and colon cancer may prolong survival in patients with invasive bladder cancer, researchers reported at the American College of Surgeons clinical congress in Chicago.

Using an extremely sensitive tool based on nanotechnology, researchers from Northwestern University, Chicago say they have detected previously undetectable levels of PSA in patients who have undergone radical prostatectomy.

The American College of Physicians (ACP) has issued a new guideline that strongly recommends that physicians initiate therapy with an oral phosphodiesterase type-5 inhibitor in men who seek treatment for erectile dysfunction unless they have a contraindication to PDE-5 inhibitors, such as nitrate therapy.

Alpha-blockers, tricyclic antidepressants, or both can improve compliance, lower pressures at bladder capacity, and improve reflux, incontinence, and detrusor overactivity in neurogenic bladder patients.

Postoperative pharmacologic therapy enhances the chances of erectile function recovery in virtually all categories of men who undergo bilateral nerve-sparing prostatectomy.

The FDA has approved a human papillomavirus vaccine (Gardasil) for use in boys and young men.

Final results from a large, 4-year study shows that combination treatment with dutasteride (Avodart) and tamsulosin (Flomax) reduces the risk of acute urinary retention or BPH-related surgery and reduces the risk of BPH clinical progression more than tamsulosin alone.

The FDA has approved GlaxoSmithKline?s pazopanib (Votrient) to treat patients with advanced renal cell carcinoma.

An investigational formulation of testosterone solution 2% (Axiron) is effective in men with hypogonadism, according to recently released results of a phase III trial examining 155 men across six countries and 26 sites.

Oxybutynin chloride gel 10% (Gelnique) appears comparable to placebo in its effect on memory tests and other cognitive functions in older healthy adult subjects when compared with immediate-release oral oxybutynin treatments, according to research presented at the International Continence Society annual meeting in San Francisco.

p>GlaxoSmithKline has filed a supplemental new drug application with the FDA for dutasteride (Avodart) for prostate cancer risk reduction among men at increased risk of developing the disease.

Endo Pharmaceuticals has announced the reintroduction of valrubicin (VALSTAR) intravesical therapy for the treatment of Bacillus Calmette-Guérin (BCG)-refractory carcinoma in situ (CIS) of the bladder for whom immediate removal of the bladder would be associated with unacceptable medical risks.

Androgen deprivation therapy leads to an increased risk of bone fractures and other side effects of estrogen deficiency in men with prostate cancer, but those effects can be successfully treated with the use of an oral selective estrogen receptor modulator, suggest the results of a large, prospective, randomized tria presented at the AUA annual meeting in Chicago.

In a phase II study, about 40% of men with clinically localized, high-risk prostate cancer were free of biochemical recurrence at 18 months when treated with neoadjuvant docetaxel (Taxotere) and ketoconazole followed by surgical excision, according to research presented at the AUA annual meeting.

The FDA has announced that boxed warnings are now included on labels of four botulinum toxin drug products, revising a previous safety alert on the products. The products also now include medication guides for patients, as mandated by FDA in April.

Advanced prostate cancer patients who are treated with oral sodium clodronate appear to have improved survival rates, according to results of a British study.

The FDA Advisory Committee for Reproductive Health Drugs (ACRHD) has recommended approval of denosumab (Prolia) for prevention and treatment of bone loss in certain prostate cancer patients.

A second and final phase III, multicenter, double-blind, placebo-controlled study of PSD502 for premature ejaculation treatment has met all endpoints, according to Sciele Pharma and Plethora Solutions Holdings. Those endpoints include intra-vaginal ejaculation latency time and the index of premature ejaculation (IPE; ejaculatory control, sexual satisfaction, and distress domains).

Genentech, Inc. has earned FDA approval for bevacizumab (Avastin) plus interferon-alfa for treatment of metastatic renal cell carcinoma. Bevacizumab blocks the vascular endothelial growth factor (VEGF) protein responsible for tumor growth.

Mylan Pharmaceuticals Inc., Sun Pharmaceutical Industries, and Sandoz Inc. have received FDA approval for their generic formulations of bicalutamide tablets, 50 mg.

Patients with inherited forms of advanced prostate, breast, and ovarian cancers caused by mutations in the BRCA1 and BRCA2 genes experienced tumor shrinkage without major side effects when treated with the investigational drug olaparib (AZD-2281), a recently published phase I study showed.

The FDA is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products? labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through secondary exposure.

Findings from a multicenter, randomized, double-blind, placebo-controlled study are consistent with previously reported data showing that tadalafil (Cialis) improves lower urinary tract symptoms associated with BPH.

Two drugs aimed at stemming bone loss in men with prostate cancer have moved closer to FDA approval.

Ferring Pharmaceuticals, USA has received FDA approval to market degarelix, an injectable gonadotropin-releasing hormone (GnRH) receptor antagonist, indicated for patients with advanced prostate cancer.