GPC Biotech AG submitted the non-clinical section of the rolling submission of a USFDA New Drug Application (NDA) for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer (HRPC).
The CMC (chemistry, manufacturing and controls) section of the NDA was submitted by the company in December 2005 and expects the completion of the NDA submission by the end of 2006.
Read more at GPC Biotech."The non-clinical section is the second of three parts necessary to complete the NDA submission. We are very pleased that we continue to make such good progress in advancing satraplatin toward the market and that we remain on track with our timelines," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer.
"The second half of 2006 promises to be of seminal importance for GPC Biotech as we expect to have the final data on progression- free survival from our SPARC registrational trial in the fall and complete the NDA filing by the end of this year."
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