DENDREON Scores a TOUCHDOWN with PROVENGE
April 14th, 2009 | Posted by Rory KearneyHISTORY WAS MADE TODAY!
A non toxic, non invasive Immunotherapy to strengthen the body’s ability to fight prostate cancer achieved its goal of being supportive of the previous trials, as required by the FDA.
Mitchell Gold, Dendreon CEO, held a conference call to announce the results of the Provenge Impact Trial.
Here are some of Dr. Gold’s words concering the results: “met its pre specified end points” “confirms results of previous studies” “data met criteria and specifications of Biologics License Application” “results were robust” “results were unambiguous and held up to multiple sensitivity analysis” “a clear hit on statistical significance”.
It was great news for long suffering prostate cancer patients who are one step closer to gaining access to Provenge.
It was great news for people around the world seeking better, more humane treatments to fight cancer. Dendreon has a pipeline of immunotherapies on the back burner.
Here at Care To Live we are ecstatic. However our work is very far from over. We need the FDA to allow the men access to Provenge NOW!
We are already getting emails from people begging for access. The FDA needs to heed their cries, and speed the approval process through. These men have already been waiting for 2 years while the FDA dawdled. They don’t have the luxury of wasting more time.
Mike Kearney had written to Andrew Schorr of Patient Power, to keep him updated. Mr. Schorr did a breaking news interview with Dr. Sam Chang, a Urologist from Vanderbilt University to find out what he thought about Dendreon’s announcement today.
At the end of the interview, Andrew said “Doctor, you sound really excited about this.” The doctor said, “Yes, not only for prostate cancer but for other cancers as well.”
Recommended listening: http://www.patientpower.info/Audio/ht/HT041409.mp3a
Our thanks go out to the entire DENDREON team in Seattle, Washington and Hanover, New Jersey for their hard work and unending dedication, and to all the Care To Live members and supporters along with Attorney Kerry Donahue for making this day possible.
Special thanks to our devoted webmaster Matt Jurmann of ChromaticSites.com
We urge the FDA to move swiftly.
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Tags: Andrew Schorr, Care To Live, CareToLive, CareToLive.com, Dendreon, Immunotherapy, Kerry Donahue, Mitchell Gold, Prostate Cancer, provenge
April 21st, 2009 at 2:19 pm
I have Stage 4 prostate cancer. I have been on hormone therapy for three and a half years and I am starting to a rise in my PSA which indicates I am developing androgen independent cancer cells. I am very excited about this drug and if there is anything I can do to convince the FDA to approve this drug quickly let me know. As the article says a lot of us may not be around when it is finally approved. We need this drug now.
August 26th, 2009 at 2:37 pm
I AM CURRENTLY A POSTATE CANCER PATIENT, AND MY PSA SHOWS I HAVE ANDROGEN
INDEPENDENT CANCER CELLS . i HAVE BEEN TAKING CHEMO AT LEAST ONCE A YEAR (TAXOTERE
AND ELDIGARD HORMO TREATMENT SINCE 2003 EVERY SIX MONTHS. I READ THE FDA NEWS RELEASE
8/12/2009, ” FINAL RULES FOR EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREAT-
MENT USE AND CHARGING FOR INVESTIGATIONAL DRUGS.” COULD THIS GIVE CERTAIN PATIENTS ACCESS TO DRUGS SUCH AS PROVENGE AT AN EARLIER DATE, AND IF SO WHAT ACTION CAN BE TAKEN WITH MY DOCTOR TO OBTAIN PROVENGE THERAPY. wE NEED THIS DRUG NOW. wHAT IS STATUS OF THE FDA APPROVAL OF PROVENGE. HOPEFULLY WAITING.