an IV Drip

 

Provenge is a promising new therapy made by Dendreon for certain types of prostate cancer.  It has shown strong efficacy to date in several studies, but concerns about how it is made played a large role in the FDA asking for more data on it in 2007.  It is up for another FDA examination later this year.

Provenge is made using your body’s own immune cells.  To do so, you are hooked up to a machine which filters out certain cells from your blood.  Those cells are then taken to a lab where they are exposed to certain elements that are a significant part of prostate cancer.  This trains them to attack those elements.

After this training, the cells are infused back into your body.  The whole process typically takes 3 injections over the course of a month.

Efficacy

The number one question people have about any treatment is, how well does it work?

The data increasingly shows that Provenge increases lifespan, or objective survival rate, in those who take it.  In one study of 127 patients, those who took Provenge lived an average of 4.5 months longer than those given placebo.  Additionally, those on Provenge were three times as likely to be alive 3 years after the start of treatment compared to placebo.

That said, the exact types of prostate cancer that best benefit from Provenge have not fully been figured out yet.

FDA Asks for More Data

When Provenge was submitted for FDA approval in 2007, it had the strong approval of an advisory committee.  The FDA decided to ignore the advisory committee’s opinion possibly due in part to three letters written to it attacking Provenge.

One of the key elements was pointing out that the studies into Provenge had not met their primary objective, of reducing the time that the prostate cancer took to progress.  Improving the objective survival rate was not the primary goal of the study so the studies were, arguably, a failure.

Considering that patients on Provenge lived a significantly longer time than those not, this decision outraged many.  Some argued that unseen political maneuvering was preventing a lifesaving medication from reaching market.

To placate the FDA, there has been an additional study run with the primary goal of increasing lifespan of those on Provenge.  This goal has been met with the latest study showing an increase in survival of around 4 months and an increase of 38% in chance of being alive at three years – for those taking Provenge.

Side effects

Less than 3% of patients are unable to complete all three infusions due to side effects.  There are similar rates of side effects in people on Provenge and on placebo.

All side effects that were considered serious resolved within 24 hours and all patients recovered.

57% on Provenge report chills

48% report fatigue

32% report pyrexia or fever

19% report headache

14% report asthenia or weakness

14% report nausea

13.6% report anemia

13% report paresthesia or tingling sensation

11% report chest wall pain

11% report dyspnea or shortness of breath

11% report vomiting

Cerebrovascular Events

The data indicates that there may be some increase in cerebrovascular events such as stroke in patients on Provenge.  One study indicated a higher rate of such incidents on those on the medication.  Due to the small numbers of participants, however, it is possible that the higher rate was in part from normal statistical variation.

Sources:

1) Treatment of prostate cancer: therapeutic potential of targeted immunotherapy with APC8015
2) Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer
3) IMPACT: Sipuleucel-T vaccine increased OS