Jim Kiefert, chair of the executive committee of US Too International prostate cancer support group, interviewed yesterday at the American Urological Association (AUA)’s annual meeting by CNBC’s pharmaceuticals reporter Mike Huckman, said some members of his support group wept when they heard FDA had delayed approval of Dendreon’s vaccine for advanced prostate cancer, Provenge. The interview with Kiefert is part of the video at this CNBC link. Meanwhile advocates are signing a petition and plan to demonstrate in Washington D.C. and hope to meet with the head of the FDA.

Data showing a substantial survival advantage for men who took Provenge ahead of Taxotere , which was presented last year at the Chemotherapy Symposium in New York, was rerepresented at the AUA May 20 by Dr. Daniel Petrylak MD.

Patient advocacy groups who testified at the Advisory Committee meeting are renewing efforts for immediate approval and have established a website, provengenow.org. The domain is owned by Thomas Farrington, head of PHEN (Prostate Health Education Network). Farrington, as he told the FDA in a letter submitted to the Advisory Committee March 26, is a seven-year survivor who “witnessed the deaths of my father and both grandfathers from this sinister prostate cancer disease.”

Provenge Now’s organizers and supporters plan to assemble on Capitol Hill on June 4. Jan Manarite, the Florida educational facilitator for the Prostate Cancer Research Institute, coordinates the Raise a Voice initiative from her home in Sanibel, FL. Manarite’s husband Dominic was diagnosed with prostate cancer 7 years ago at age 58.

“This is going to happen,” Manarite told psa-rising.com in a phone interview. “We are moving forward.” The organizers expect to meet privately with FDA head Dr. Andrew von Eschenbach on June 4, Manarite said.

“It must be human,” Manarite said, “to get so caught up in an argument that we lose sight of the foundation — we get lost,” adding: “We’re in a new era of science, where we’re trying to evaluate immunotherapy in cancer and it’s so important to humanity. We mustn’t throw this away.”

As part of the Provenge Now campaign, malecare.com is hosting a petition drive.

After the Advisory Committee March 29 voted 17-0 for the immunotherapy’s safety and 13-4 for its substantial effectiveness, letters of dissent were obtained by The Cancer Letter from oncologists Howard Scher MD and Marta Hussain MD and biostatistician Thomas Fleming PhD.

On May 9 Dendreon announced receipt of an FDA “Complete Response” letter (also called an “approvable” letter) requesting more clinical data. Dendreon’s CEO Mitchell Gold, in a conference call with major investors May 10, said FDA’s decision was “very disappointing for all of us and comes as quite a surprise.” Gold said the company’s commitment is “resolute.” FDA is asking for additional “clinical data,” Gold said, but “have not specified what kind of clinical data we might provide.”

Dendreon’s application received FDA fast track status following a re-analysis of data from 2 relatively small Phase III clinical trials, one of which had been halted for failure to meet its declared endpoint (Time to Progression). The re-analysis showed evidence of a a 4.5. month median gain in overall survival for men who took the vaccine. A further randomized Phase III clinical called IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) is ongoing, with at least 324 patients enrolled and 500 planned for full enrollment. Although no one has said so for sure, FDA may wish to see this trial reach full enrollment before taking a “peek” at the data there.