Satraplatin Review by FDA

News Update 10/30/07 GPC Biotech AG and Pharmion Corporation today announced topline overall survival results for the double-blinded, randomized satraplatin Phase 3 registrational trial, the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer).  The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC).  The companies reported that the trial did not achieve the endpoint of overall survival (p=0.80, stratified log rank analysis).  The median was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group and the hazard ratio was 0.97 (95% CI: 0.83, 1.13).  The companies are currently conducting pre-specified subset analyses.   News Update 7/25/07 FDA Oncologic Drugs Advisory Committee Recommends that FDA Wait for Overall Survival Results from Satraplatin Phase 3 Trial   GPC today announced that the Oncologic Drugs Advisory Committee (ODAC) for the U.S. Food and Drug Administration (FDA) recommended (12-0) that the FDA should wait for the final survival analysis of the SPARC trial before deciding whether the satraplatin application is approvable for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed. The FDA is not bound by the recommendations of advisory committees but will consider their advice when reviewing an applicant’s NDA.

“Raise A Voice” is seeking to organize a prostate cancer presence at the ODAC meeting on July 24th to be held at the FDA Center in Rockville Maryland. At the meeting, the Oncologic Drugs Advisory Committee will consider an approval recommendation for ORPLATNA (satraplatin capsules) by GPC Biotech Inc. for proposed indication for the treatment of patients with androgen independent (hormone refractory) prostate cancer (HRPC) that has failed prior chemotherapy. The deadline to register to provide oral comments at the meeting is July 2nd. The deadline to submit email comments is July 10th. Details of the meeting and how to submit requests are below.

Comments relative to prostate cancer will be heard between 3:30 and 4:00. If you are planning to attend and give comments, please register by July 2nd. If you can’t do this, try calling Johanna Clifford (301-827-6761) to ask for a late registration.

If you are planning to attend the meeting and give comments or observe, please contact Jim O’Hara [johara@pcri.org or 770-632-2899] or Jan Manarite [jmanarite@pcri.org or 239-395-0995] of Raise A Voice to obtain additional information regarding logistics.

In any case, please send electronic comments regarding Satraplatin NDA 021-801 to the FDA: Johanna.lifford@fda.hhs.gov

Where: FDA Advisors and Consultants Staff Conference Room, 5630 Fishers Lane, rm. 1066, Rockville, MD 20857.

When: Tuesday, July 24th; 8:00 am to 5 pm. Satraplatin is scheduled to be covered after lunch, with one half hour of public comment from 3:30 to 4:00.

Details: See the FDA announcement.

Plan: Raise A Voice would like to help coordinate a visual presence at this meeting. We will be passing out blue lanyards for everyone to wear. This will create something that the committee can easily see, as far as support of the prostate cancer community.

PLEASE FORWARD this information to anyone who would like to “Raise A Voice” for better treatments for men with prostate cancer that has progressed on androgen deprivation.

Here are some fast facts about ORPLATNA (satraplatin capsules):

• Satraplatin is an orally administered platinum compound currently under investigation for the treatment of patients with advanced hormone-refractory prostate cancer (HRPC) that has failed prior chemotherapy.
   
• At the 2007 AUA and ASCO meetings, researchers affiliated with the multination randomized trial, SPARC, reported that Satraplatin (S) is well tolerated and has clinically relevant activity for the treatment of patients with HRPC. 950 pts were accrued to the study over 28 months. Treatment with S resulted in a 40% reduction in the risk of disease progression over placebo (HR = 0.6; 95% CI: 0.5-0.7;P <.001). The effect of S on PFS increased over time. At median PFS, the improvement was 13% (11 vs 9.7 weeks), reaching 89% at the 75th PFS percentile (36 vs 19 weeks). S was equally effective regardless of whether or not patients received prior docetaxel treatment. Pain response rate was significantly higher in patients receiving S (24.2% vs 13.8%, P < .005), as was PSA response rate (25.4% vs 12.4%, P < .001), and median time to pain progression (66.1 vs 22.3 weeks, P <.001). The most common toxicities were myelosuppression (thrombocytopenia, neutropenia) and GI toxicities (nausea/vomiting, diarrhea), which were generally mild to moderate.
   
• For more information about Satraplatin
   
• For Preliminary results of Phase III SPARC trial

Here are some facts about advanced prostate cancer:

• For early stage prostate cancer there are approved treatments that provide effective control for many. We encourage these men to utilize available treatments or to seek out clinical trials.
   
• Men diagnosed with prostate cancer that is not confined to the prostate or who have recurrence following local therapy have advanced prostate cancer. Advanced Prostate Cancer progresses to to Androgen Independent (AIPC), also known as Hormone Refractory (HRPC), disease for which there is only one FDA approved treatment.

For more information on Raise A Voice
 

Prostate Cancer Research Institute (PCRI)
 

Material provided by PCRI is intended for educational purposes for discussion with your physician and should not be considered as medical advice. Information and opinions expressed on this website are not an endorsement by PCRI for any treatment, product or service.