When will Provenge get approved?

According to a media release issued yesterday by Dendreon, the company now expects to submit a revised New Drug Application for sipuleucel-T (Provenge) to the US Food and Drug Administration (FDA) in November this year. This might allow the FDA to approve the product by June 2010 or maybe earlier.

It was also clear from the media release and from comments by Dendreon executives associated with that media release that it will take time for Dendreon to “ramp up” manufacturing capacity for Provenge. It has been evident for a while that the company would probably not be able to meet initial demand for the product when it first gets approved. Clearly the company will need to put a transparent system in place that will allow a fair means of access to this therapy until full production capacity is available in late 2010 or 2011. In the past, companies have used patient lotteries and/or restricted access exclusively to patients who met the strict approval criteria for the product in situations like this.

It is worth remembering that Provenge is not a “drug” in any normal sense of the term. Provenge is strictly a form of individual cell-based immunotherapy in which cells from the patient’s own body are extracted, modified, and then re-infused back into the patient. Every single dose of Provenge therefore has to be individually created.

Interestingly, Dendreon also announced yesterday that they are putting in place a process that will allow each patient and his doctor to know exactly where their individual doses of Provenge are in the “manufacturing” process. The so-called Intellivenge system sounds similar to the type of tracking system that companies like Federal Express uses to let you know exactly where a package is in its journey from the sender to the addressee.

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