GPC Biotech (Nasdaq: GPCB ) announced yesterday that it has withdrawn its New Drug Application for Satraplatin after the Oncologic Drugs Advisory Committee recommended that the FDA wait for the final results of GPC's clinical trial before approving the drug.
The company was trying to get Satraplatin approved to treat hormone-refractory prostate cancer in patients whose prior chemotherapy has failed. Because of the lack of treatments for patients with late-stage prostate cancer, the FDA had given Satraplatin priority review and a decision was expected in August.
The drug maker could have left the NDA in place and hoped that the FDA would rule against the advisory panel, but given the ominous briefing document that the FDA submitted to the committee, that outcome seemed as likely as Paris Hilton actually leading a simple life.
The issue revolves around how much data from the most recent phase 3 clinical trial is required for approval. The interim survival data, taken after 463 patients had died, showed a strong trend toward increased survival in the subjects treated with Satraplatin. GPC had originally planned to wait until 700 patients had died before submitting the data, but got tired of waiting and thought that the data was good enough to get an approval.
There is something twisted about having to wait to get a drug to market because it's performing better than expected. Of course, if the drug was head-over-heals better, then GPC could prove to the FDA that there was already a statistically significant difference between the two treatment groups and the FDA would stop the trial early. That's what happened to Onyx Pharmaceuticals' (Nasdaq: ONXX ) and Bayer's (NYSE: BAY ) label-expanding trial for liver cancer. When the drug works that well, the FDA stops the trial so that the subjects that are receiving placebo can be switched to the active drug.
It will be interesting to see whether Satraplatin can squeak through in Europe without the additional data. GPC licensed the drug from Spectrum Pharmaceuticals (Nasdaq: SPPI ) in 2002, and it out-licensed the European marketing rights to Pharmion (Nasdaq: PHRM ) . On Friday, Spectrum and Pharmion announced that the European Medicines Agency has accepted its application for marketing authorization for Satraplatin in combination with Prednisone to treat patients who've failed chemotherapy. Sometimes the two medical agencies don't see eye to eye, so it's possible that Satraplatin will receive approval in the EU before the U.S.
Extrapolating from the deaths that have occurred so far, the complete trial data is expected in about six months. Assuming the trend in survival continues, Satraplatin will resubmit a new NDA soon thereafter and likely receive marketing approval within six months. Dietmar Hopp, one of SAP's founders, appears to agree with my forecast. He reportedly raised his stake in the company from 10.13% to 14.5% last week, causing the stock price to jump more than 20% yesterday.
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Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.
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