Tasquinimod (TASQ)- A New Phase 3 Trial Shows Promise To Slow Disease Progression

Results from a recent international randomized phase II trial for the drug tasquinimod (TASQ), shows that TASQ is a potential therapy for men with advanced prostate cancer. The men who received TASQ on average went twice as long without disease progression as those who received only a placebo. […]

Changes of PSA Doubling Time is Associated with Disease Progression in Men with Biochemically Relapsed Prostate Cancer Treated with Intermittent Androgen Deprivation

Researchers at the The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, Maryland studied the relationship between the change of PSA doubling time (PSADT) and disease progression during intermittent androgen deprivation (IAD) therapy for prostate cancer. They retrospectively analyzed the data from 96 men diagnosed with biochemically relapsed prostate cancer (BRPC) who [...]

Dendreon Gets FDA Approval for Extra Work Stations at their New Jersey Factory

On March 10th (my birthday) Dendreon announced that it has obtained clearance of its new work stations from the FDA. The result of this clearance is the quadrupling the output from the New Jersey factory where it makes sipuleucel-T (Provenge). When Dendreon obtained FDA clearance in April of 2010, it had extremely limited manufacturing capabilities [...]

CME Advisory Committee Supports Medicare Payments for Provenge for Men Meeting the FDA Guidelines

The Centers for Medicare and Medicaid Services (CME) decided to review their policies pertaining to paying for Provenge, which costs $93,000 per man. Since the hearings which were held a number of months ago, we have not heard any feedback. Despite this, most of the regions have been paying for the treatment, however there have [...]

New Phase 2 Trials For MDV3100 Begins & Another To Start Soon – On The Horizon

It was announced today that the first patient in the TERRAIN study received their first dose in the Phase 2 trial of the investigational drug MDV3100 . MDV3100 is a triple-acting oral androgen receptor antagonist that I have writing about as a drug “On The Horizon”. Triple-acting means that it blocks testosterone binding to the [...]

Study Shows that Six Months of Neoadjuvant ADT Significantly Reduces Mortality in Locally Advanced Prostate Cancer

Researchers from the Trans-Tasman Radiation Oncology Group 96.01 trial study (TROG 96.01) concluded that six months of treatment with neoadjuvant androgen deprivation combined with radiation reduced the risk for disease-specific death by 49% in men with locally advanced prostate cancer. […]

The Latest on the Expanded Access Trial for Abiraterone- New Locations

ABIRATERONE EXPANDED ACCESS Trial Site Contact Info – 3/25/11 for men with advanced prostate cancer (800) 457-6399 M-F, 9am –5pm, EST TRIAL link: http://www.clinicaltrials.gov/ct2/show/NCT01217697?term=abiraterone&recr=Open&rank=6 Basic Criteria: 1. testosterone less than 50 2. metastatic prostate cancer 3. no brain metastasis 4. failed chemo 5. no more than 2 different types of previous chemo […]

Bristol-Myers Squibb Wins U.S. Approval for Ipilimumab to Treat Melanoma – Good News for Men with Advanced Prostate Cancer

Bristol-Myers Squibb Co. announced today (March 25) that it has received FDA approval for ipilimumab, the first drug in a new family of medicines to treat advanced melanoma, the most deadly form of skin cancer. This is potentially good news for those of us who are fighting advanced prostate cancer as there is currently an [...]

FDA Perspective on Developing Novel Combination Therapies – What We Need

Increasingly it has become obvious to me and to many other individuals that our current drug approval and development process has a basic flaw. If you go to research conferences you quickly learn that there is probably no magic bullet to stop any type of cancer, including advanced prostate cancer. Current drug development focuses on [...]

Study Results Provide Evidence for First-Line Use of Firmagon (degarelix) in Advanced Prostate Cancer

Firmagon, the newly FDA approved gonadotropin-releasing hormone (GnRH) receptor blocker should perhaps be considered as a better alternative to the traditionally used ADT drugs like lupron and zoladex (GnRH agonists) which are the current standard of care. Recent data released from the ongoing five-year Firmagon (degarelix) extension study (CS21a) has demonstrated the long term efficacy [...]

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