GPC Biotech has said that the FDA has accepted its new drug application for satraplatin for prostate cancer and has granted the drug priority review.
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GPC Biotech is requesting the approval of satraplatin as a treatment in combination with prednisone for patients with hormone-refractory prostate cancer whose prior chemotherapy has failed.
Priority review designation is intended for products that address unmet medical needs and speeds up the review of the drug to six months from the date of submission.
“If approved, we believe that satraplatin has the potential to become an important therapy for hormone-refractory prostate cancer patients whose disease has progressed after prior chemotherapy, an area of unmet medical need,” said Bernd Seizinger, CEO.
Satraplatin is a member of the platinum family of compounds. Platinum-based drugs are a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home.
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