Dendreon Makes History: FDA Approves First Active Immune-Booster to Fight Cancer

4/29/10Follow @xconomy

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of winning FDA approval for Provenge. Dendreon’s release made it sound like it was stunned, as the company needed to seek “clarification” from the FDA about what it really meant.

All that stock wealth was wiped out in a heartbeat. Dendreon stock collapsed from $17.74 the previous day to close at $6.33. Trading volume skyrocketed, again making Dendreon the world’s most active stock that day. Patient advocates were outraged. The inevitable shareholder lawsuits arrived.

The recriminations in the wake of the FDA rejection got ugly at times. Some infuriated individuals went so far as to physically threaten Hussain and Scher before they appeared in public at the American Society of Clinical Oncology (ASCO) meeting the following month, forcing officials there to tighten up security. The Provenge advocates continued their fight, urging members of Congress to hold hearings and investigate the FDA’s decision. No hearings were held.

Dendreon, once a highly visible and promotional company, had little to say at that year’s ASCO meeting and didn’t make much news the rest of the year. It sought to pick up the pieces and find a new way forward. After yet another meeting with the FDA, the two sides agreed on a compromise of sorts that could get the agency the proof it needed to be confident Provenge works in the study of 500 men.

Now that the Dendreon drama is moving further in the past, it has gotten researchers thinking big again about immunotherapy in the future. Dr. Corman, the Virginia Mason urologist, noted that the Impact trial looked at men who are quite sick, who have had their immune systems weakened by their cancer and rounds of radiation therapy. Might Provenge be even more effective if it were given to men with earlier-stage forms of the disease, who still have more robust immune systems that are more likely to respond to the priming from Provenge?

That’s a question Dendreon has had on its mind for years, but it is a difficult one to answer because early-stage prostate cancer is so slow-growing it would take many years to show a definite survival advantage of the drug over the placebo.

“The benefit should be greater in men who are younger, with healthier immune systems,” Corman says.

How much demand will there be from patients? It’s likely to be high because Dendreon’s public saga with investors and the FDA, it already has unusual name recognition already without spending any formal marketing dollars. Provenge had 93 percent brand awareness about a year ago, according to a Dendreon survey of targeted physicians, which CEO Mitchell Gold cited at last year’s annual shareholder meeting.

Corman has found a way to help some of his patients get access to the drug prior to FDA approval through what amounts to a really large clinical trial. He’s expecting the phone to start ringing shortly from patients as news spreads of the FDA approval.

“There will not be 50 patients on our doorstep here on Day 1, but there might be five,” Dr. Corman says.

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