The USFDA has accepted the submitted New Drug Application (NDA) of GPC Biotech AG (Nasdaq: GPCB) for satraplatin in combination with prednisone for patients with hormone-refractory prostate cancer (HRPC) whose prior chemotherapy has failed.
The USFDA has granted Priority Review Status to the said NDA.
Priority review designation is intended for those products that address significant unmet medical needs and sets the target date for FDA action at six months from the date of submission.
A member of the platinum family of compounds, Satraplatin is an investigational drug that is orally bioavailable and is given as capsules that patients can take home, unlike other platinum-based drugs currently in the market that are administered intravenously.
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