There has been a flurry of media stories as the “drop dead date” for a decision about approval of sipuleucel-T (Provenge) gets closer and closer.
ABC News has a piece recounting the long saga of how Provenge did not get approved back in 2007 (a decision that shocked some and made perfect sense to others). The story comes with some video about the next projected major drug for prostate cancer (abiraterone acetate) — which seems a little odd.
CBS News had another story yesterday by medical correspondent Jennifer Ashton, MD, covering the projected approval.
A HealthDay report was running on the Businessweek web site.
Fox News got into the act with a story by medical correspondent Sapna Parikh, MD (although someone spelled the name of the drug wrong), and so did Examiner.com in Philadelphia.
Down in Virginia, the Virginian-Pilot had a story about the involvement of a local prostate cancer specialist in the clinical trials of Provenge, going back nearly a decade.
Even The Times of India had picked up on the excitement — although the chances that Provenge will be available in India in the near future seem a little small.
Bottom line? We haven’t seen this much excitement about the approval of a prostate cancer drug ever. Is the FDA going to deliver?
Filed under: Drugs in development, Management, Treatment | Tagged: media, Provenge, sipuleucel-T |
THE "NEW" PROSTATE CANCER INFOLINK 
Have you EVER seen such spin, spin, spin.
Here’s a bet that, if the FDA doesn’t approve, that the next step will be sad stories about men who would have lived if they had access to this wonder drug that heartless bureacrats won’t approve. Write in’s, YouTube campaigns etc. — anything to put the heat on.
Spin, spin, spin
It is my understanding that if approved Provenge will only be available for late stage patients. If this is the case why wouldn’t they be allowed to try it on early stage patients. Obviously if approved it is deemed safe to use. Any ideas on this.
As I have pointed out elsewhere, what a drug is approved for is based on the clinical trials that were carried out. To date we only have data demonstrating the effectiveness and safety of sipuleucel-T in men with hormone-refractory prostate cancer. It is therefore a near certainty that an approval will be for patients who meet criteria for hormone-refractory disease.
However, this does not mean that the drug can’t get used for patients with earlier stages of disease. What it means is that insurance companies and Medicare (in the USA) are highly unlikely to be willing to pay for the costs associated with treatment of patients with earlier stages of disease, because there are no data to support such use. I am sure there will be some patients and doctors who are willing to take/prescribe sipuleucel-T outside its approved indication. The unanswered question at this time is whether the manufacturer will be willing to custom-manufacture sipuleucel-T for patients who do not have hormone-refractory prostate cancer, or whether they will be willing to do that only under pre-specified conditions. Of course any such patients are going to have to pay for the treatment out of their own pockets — which is liable to be expensive.
It is worth bearing in mind that clinical trials of the use of sipuleucel-T in earlier disease stages have already started.
Please see the announcement about the approval of Provenge earlier today (April 29).
It does appear as though Dendreon will — at least initially — be seeking to limit access to patients who meet precise approval criteria for this drug.