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GPC Biotech Takes Satraplatin Off Fast Track

The biotech withdraws its new-drug application for accelerated approval of the prostate cancer drug.

GPC Biotech's (GPCB) stock rebounded Monday after the company withdrew its new-drug application (NDA) for accelerated approval of prostate cancer drug satraplatin.

Last week the Oncologic Drugs Advisory Committee unanimously recommended that the Food and Drug Administration

wait for survival data from the SPARC trial before deciding whether to approve the drug, which was licensed to GPC by

Spectrum Pharmaceuticals

(SPPI) - Get Spectrum Pharmaceuticals, Inc. Report


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The data are expected in six months but are dependent on the death rates in the trial, a difficult factor to predict. "We look forward to receiving the overall survival data from the SPARC trial and to the resubmission of the NDA to the FDA next year," said Spectrum's Chief Scientific Officer Luigi Lenaz.

A brief by ODAC preempting last week's meeting -- which caught some investors by surprise with a discouraging outlook for the accelerated approval of satraplatin -- followed by the panel's unanimous decision, sent shares of both GPC and Spectrum tumbling. But upon withdrawing the NDA Monday, GPC gained $1.57, or 15.2%, to $11.92, and Spectrum gained 5 cents, or 1.3%, to $4.05.

Spectrum also said Friday that the European Medicines Agency accepted an application for marketing authorization for satraplatin in combination with prednisone to treat prostate cancer patients who've failed chemotherapy.



has the right to market the satraplatin in Europe.

Pharmion was up 5 cents, or 0.2%, at $24.47 in recent trading Monday.