Provenge News and Research

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FDA approves new treatment option for prostate cancer

Today is an exciting day for men with advanced prostate cancer and the millions of families and loved ones who are profoundly affected. Today a new prostate cancer treatment option, Provenge, was approved by the Food and Drug Administration.

30 Apr 2010

Provenge cellular immunotherapy for men with advanced prostate cancer receives FDA approval

The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

30 Apr 2010

EndoChoice granted FDA marketing clearance for BONASTENT Esophageal and Biliary Stent platforms

EndoChoice, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its BONASTENT® Fully Covered Esophageal Stent for the treatment of malignant esophageal obstructions, and its BONASTENT Uncovered Biliary Stent for the treatment of malignant biliary obstructions.

30 Apr 2010

FDA approves Provenge prostate cancer vaccine

Cancer may now be fought with a vaccine. The FDA has finally approved an immune boosting vaccine which is said to extend survival of patients at an advanced stage of prostate cancer by four months. This is twice as long as what could be expected with regular chemotherapy. There is also an increase of three years survival after detection in initial stage by 38% thanks to the vaccine.

30 Apr 2010

Updated report analyzing approval rates at FDA published

Sagient Research Systems, a leading publisher of independent research for the financial services, institutional investment and corporate intelligence communities, recently published an updated report analyzing approval rates at the U.S Food and Drug Administration. According to its research service, BioMedTracker, the rate of drugs that were approved by the FDA in 2008 and 2009 has remained close to the historical low seen in 2007.

7 Apr 2010

Global market for oncology drugs is forecast to reach $80 billion by 2050

New Medicine's Oncology KnowledgeBASE (nm/OK) residing at http://nmok.net became available on the Internet 10 years ago and, since then, the oncology field has evolved into one of the most challenging, complex and promising drug development sectors, both in terms of its potential contribution to medicine and to its market opportunities.

29 Jan 2010

FDA acknowledges Dendreon's amended BLA for PROVENGE as a complete response

Dendreon Corporation today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA. Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC).

20 Nov 2009

Dendreon submits an amended BLA for PROVENGE active cellular immunotherapy

Dendreon Corporation today announced that it has completed the submission of the amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T), the Company's lead investigational product, to the U.S. Food and Drug Administration (FDA). Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC).

2 Nov 2009

Cutting Edge Information hopes to see ill patients have speedier access to potential cures

The FDA has approved the first set of vaccines aimed at preventing H1N1 infection after an approval process of less than four months. Cutting Edge Information is currently analyzing the lessons learned that may emerge for both the Food and Drug Administration (FDA) and life science firms after this crisis experience.

1 Oct 2009

Results of PCF funded study could impact the standard of care for prostate cancer patients

Twice-yearly intravenous infusion with denosumab, a new targeted therapy to stop bone loss, increased bone density and prevented spinal fractures in men receiving androgen-deprivation therapy for prostate cancer. The report from an international research study, the first to document reduced fracture risk in men receiving the hormone-blocking treatment, was published today in the print edition of the New England Journal of Medicine (NEJM). Both fundamental research on rank ligand (RANKL) in prostate cancer bone metastasis and other molecular factors involved in the denosumab study were supported at Massachusetts General Hospital with funding from the Prostate Cancer Foundation (PCF).

21 Aug 2009

Dendreon signs lease for new manufacturing facility in Union City, Ga

Dendreon Corporation (Nasdaq: DNDN) today announced it has signed a lease agreement with Majestic Realty Co. to build a 160,000 square-foot manufacturing facility in Union City, Ga., where it expects to manufacture PROVENGE(R) (sipuleucel-T) for patients with advanced prostate cancer. The state of Georgia will be hosting a ribbon-cutting ceremony on September 30.

10 Aug 2009

Experimental immunotherapy significantly prolongs survival in men with advanced prostate cancer

Sipuleucel-T (Provenge), an experimental immunotherapy improved survival in men with metastatic disease, according to new results to be presented April 28 at the American Urological Association (AUA) Annual Scientific Meeting in Chicago.

29 Apr 2009

Experimental vaccine increases survival in men with prostate cancer

Below is a comment from Otis W. Brawley, M.D., American Cancer Society chief medical officer, on the announcement that the experimental vaccine Provenge increased survival in men with prostate cancer.

14 Apr 2009

Are we looking at cancer vaccine trials the wrong way?

Ongoing therapeutic cancer vaccine trials have yet to show evidence of vaccines spurring a patient's immune system to shrink tumors -- yet patients who receive these vaccines in trials tend to live longer and respond better to subsequent treatment.

4 Jul 2007

Rethinking therapeutic cancer vaccine trials

3 Jul 2007

Findings from study of immunotherapy vaccine in prostate cancer patients

Data from an ongoing study designed to explore the biologic and clinical activity of cancer immunotherapy sipuleucel-T, or Provenge, in patients with early stage recurrent prostate cancer who have a rising serum prostate specific antigen (PSA) level, but who have not yet developed metastatic disease will be presented by Oregon Health & Science University Cancer Institute researchers.

5 Jun 2007

New study could bring hope to men who don't respond well to hormone therapy for prostate cancer

More than 1 million American have prostate cancer, the leading non-skin cancer in men in the United States. Last year alone some 220,000 new prostate cancer cases were reported, and 28,900 men died of it.

25 Jun 2004