GPC Biotech withdraws satraplatin NDA
Application (NDA) for accelerated approval following last week's
less than glowing recommendation to hold off on its approval.
Approval of the oral satraplatin formulation for the treatment of hormone-refractory prostate cancer, the first platinum-based oral cancer drug, was looking promising when it was granted a priority review status in April this year following positive trial results.
But a disappointing review last week by the US Oncologic Drugs Advisory Committee (ODAC) recommending the US Food and Drug Administration (FDA) hold back on approving the drug, dealt a blow to the German company leading to this week's decision to withdraw the NDA for accelerated approval.
The ODAC recommended that the FDA should wait for the final survival analysis of the SPARC (Satraplatin and Prednisone Against Refractory Cancer) trial before deciding whether satraplatin was approvable.
Although the FDA is not bound by the ODAC opinion, the agency would have been likely to take the recommendation seriously when considering the new drug application.
The FDA was due to make a decision on the drug's status by August 15.
"While we were very surprised and disappointed by last week's ODAC outcome, we need to move forward," GPC Biotech chief executive Bernd Seizinger said in a statement.
"Thus, we are focussing our efforts on the overall survival results from the satraplatin SPARC trial and integrating these data into the strongest possible NDA submission.
If these data are positive, we plan to submit an NDA to the FDA as quickly as possible."
The company anticipated overall survival results from the SPARC trial to be available within six months, though this timing would be based on an extrapolation of death rates in the trial and may change.
Meanwhile, satraplatin has been accepted in Europe for a marketing authorisation review.
The SPARC trial, now in Phase III, is evaluating satraplatin plus prednisone versus a placebo plus prednisone in 950 patients with hormone-refractory prostate cancer (HRPC) whose prior chemotherapy has failed.
Satraplatin is currently available in an intravenous formulation, but the oral formulation would be a first, and considering the unmet need of treating HRPC, the drug had been seen as having a good chance of approval.
GPC Biotech also announced last week that it had been sued in the United States District Court, purportedly in a class action lawsuit on behalf of all persons who purchased or acquired securities of GPC Biotech between December 5, 2004 and July 24, 2007.
The complaint alleges that GPC Biotech violated US federal securities laws by making false public statements relating to the prospects of satraplatin and thereby artificially inflating the price of GPC Biotech securities.
GPC said in a statement that it believed the allegations to be without merit and intended to vigorously defend itself.
In 2002, Spectrum Pharmaceuticals licensed worldwide rights to satraplatin to GPC Biotech.
GPC Biotech is responsible for all costs associated with the development and regulatory filings of satraplatin.
In December 2005 GPC Biotech signed a co-development and license agreement with Swiss firm Pharmion, through which the company was granted exclusive commercialisation rights to satraplatin in Europe and other territories.
