Continued focus on expanding clinical data:
Presented data at AUA that further analyzed Phase III IMPACT data to identify prognostic variables that may support early administration of PROVENGE after diagnosis of metastatic castrate resistant prostate cancer
Actively evaluating partnering strategies for European expansion; continuing to enroll patients in the sipuleucel-T European Union open-label study; expect a regulatory decision in Europe in the second half of 2013
Completed enrollment of PROVENGE and ADT sequencing study; presented initial data at ASCO-GU and expect to present additional data in 2013
Completed enrollment of PROVENGE and Zytiga®(abiraterone) sequencing study; presented initial data at ASCO-GU and expect to present additional data in 2013
NBS can supply in EU however there are other options.
[Professional Services Close - Up]
Dendreon Corp. announced the presentation of three Provenge (sipuleucel-T) abstracts from new and ongoing clinical trials at the 2013 American Urological Association Annual Meeting in San Diego, Calif.
These presentations at AUA provide the medical community with possible new insight on the role of PROVENGE in men with advanced prostate cancer," said E. David Crawford, M.D., professor of surgery, urology, and radiation oncology, and head of the section of urologic oncology at the University of Colorado, Denver School of Medicine. "PROVENGE is an innovative treatment option that uses a patient's own cells to activate the immune system to fight the disease, and these data reinforce what we have seen in the clinical setting
New Building for the Bristol Urological Institute by 2014
Steve Webster, Finance Director of North Bristol NHS Trust announced that “the Trust and partner University of Bristol have begun the second phase of the Learning and Research (L & R) Building programme at Southmead. A planning application has been made to Bristol City Council to extend the existing L & R Building. The four-storey, 3,000m2 extension will accommodate staff and services relocated from Frenchay and facilities currently sited where the second phase of the new hospital will be built. This expanded building will also offer replacement laboratory and office-based research facilities for the University of Bristol as well as accommodation for the Trust's Bristol Urological Institute and the Regional Quality Control laboratory. Building work is expected to start in early 2013 and likely to finish by summer 2014. The completed building will be a terrific resource and further enhance our reputation as a centre of excellence”.
In 2010, the FDA approved the chemotherapy drug cabazitaxel (Jevtana) for patients whose condition has worsened during or after treatment with docetaxel. Chemotherapy is sometimes recommended for men with prostate cancer that does not respond to hormone therapy.
In 2010, the FDA approved the first prostate cancer “vaccine” for select men with advanced prostate cancer. Sipuleucel-T (Provange) uses a patient’s own immune cells to fight cancer. In clinical trials, it extended survival by about 4 months.
Archive for Provenge. May. 08. 2013. The AUA Issues Specific Guidelines for the Treatment of Men with Castrate Resistant Prostate Cancer ... presentations at the recent American Urological Association meeting, however the one item that will
Posted by: Joel | Comments (0)
There was a lot of interesting and important presentations at the recent American Urological Association meeting, however the one item that will have the most impact on men with advanced prostate cancer is the new guidelines that were proposed for the treatment of men with castrate resistant prostate cancer.
The guidelines were organized by creating six different “indexes” which describe the disease state being treated. The indexes are:
1. Asymptomatic non-metastatic CRPC
2. Asymptomatic or minimally-symptomatic, mCRPC without prior docetaxel chemotherapy
3. Symptomatic, mCRPC with good performance status and no prior docetaxel chemotherapy
4. Symptomatic, mCRPC with poor performance status and no prior docetaxel chemotherapy
5. Symptomatic, mCRPC with good performance status and prior docetaxel chemotherapy
6. Symptomatic, mCRPC with poor performance status and prior docetaxel chemotherapy
In each index the committee designing the guidelines indicated what drugs would be appropriate for each disease index. In reviewing each index it is clear that the members followed the specific FDA prescribing label for each disease state, defined by the committee as being evidence based, thus not allowing any creative flexibility by a doctor. One can hope that oncologists and urologists treating men with advanced, metastatic prostate cancer will still feel empowered to diverge from the guidelines at the appropriate moments.
The full guidelines, along with the description of each index can be seen at the AUA website at: Guideline.
The AUA has also published a flow chart of this guideline which can be viewed at: Flow Chart
Joel T Nowak, M.A., M.S.W.
The AUA Issues Specific Guidelines for the Treatment of Men with Castrate Resistant Prostate Cancer
I had the opportunity to be in Chicago at the annual meeting of the American Urological Association (AUA) for the presentation of the Dendreon corporation successful clinical trial results for the first ever prostate cancer vaccine – PROVENGE.
PROVENGE trial results surpassed the survival benefits agreed to by the FDA as necessary for it to be approved as an available treatment. Provenge enhances the patient’s own immune system to fight prostate cancer. The first IMMUNOTHERAPY treatment of this type for any cancer; a landmark medical breakthrough.
PHEN has worked with and supported Dendreon over the past few years in the company’s quest to gain approval for PPROVENGE. Dr. Mitchell Gold, Dendreon president, presented at PHEN’s 2006 African American Prostate Cancer Disparity Summit on Capitol Hill, and he is committed to making certain that Provenge is available to the men who suffer disproportionately from prostate cancer.
Thomas A Farrington
PHEN President and Founder
My statement which was presented at the AUA press conference on PROVENGE, Tuesday, April 28th is below.
Farrington Statement on Provenge at AUA
Dendreon Provenge Data Release
The official release on the Provenge clinical trials results. Provenge Data
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