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Advanced Prostate Cancer: What's NEXT For FDA Approvals?

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Posted 10/30/2014 10:38 PM (GMT 0)
Hello To All ~

Does anyone out there have the latest insight as to what new medications or treatments are getting close to F.D.A. approvals for advanced prostate cancer patients ?

Are there any projected F.D.A. approvals that might be approved in 2015 from recent clinical trials that have been successful ?

Just wondering if anyone has direct insight into what might be coming around the corner that would constitute a new breakthrough for advanced prostate cancer patients in the near future.

Thanks to one and all for sharing your expertise, insight, and compassion to others on this website !
Posted 10/30/2014 10:57 PM (GMT 0)
Hi Cyclone,

It could be helpful if you posted your stats RE: where you are with advanced PCa. I myself posted this same question last week and if you become H/refractory as my husband has, it was mentioned combining treatments such as HT/with Provenge.
We have been battleing this monster for 3 years and some have had great success with combo drugs.
There is always trials going on and we hope the future will hold some kind of remission for everyone, but especially us that have aggressive PCa.

BOOGEE
Posted 10/31/2014 1:28 AM (GMT 0)
Cabazantinib is a possibility though I expect the big news for 2015 being the re-sequencing of some drugs. But I guess the question is do you mean for early stage prostate cancer? Late stage? Refractory?

For the advanced guys
1. Cabazantinib (XL-184) 50/50% chance for 2015
2. Early use of Enzalutamide (Xtandi before Chemo) This will happen possible before 2015
3. Abiraterone or Enzalutide with various combinations.

Unfortunately, 2015 will see a drop off in federal funding by a large number. They account for the largest portion of independent trials the NCI was hit with heavy cuts. That won't affect trials that are completed this year that qualify for approval. But future trials not funded by the private industry will be reduced for future years.

The next significant approval will be putting Xofigo back on the market. It is right now unavailable due to production issues.
Posted 10/31/2014 4:12 AM (GMT 0)
Tony....not sure what you mean by early use of Xtandi....Ive never had chemo yet and I went from Zytiga to Xtandi in no clinical study or anything.
Posted 10/31/2014 7:34 PM (GMT 0)
/sites.google.com/site/prostatecancerpipeline/

Partial list of new drugs in the pipeline.

Post Edited (robertC) : 10/31/2014 1:39:41 PM (GMT-6)

Posted 11/1/2014 12:02 AM (GMT 0)
Casper, you are correct that the FDA approved Xtandi before chemo last month. There are clinical trials in the works for using it among hormone-naive guys, but I wouldn't count on FDA approval for that before 2016. Medivation and Astellas just announced a Phase 3 trial for its use in recurrent PC after original RP or RT, so it will be several years until results are in.

Medivation and Astellas Announce Phase 3 Study of Enzalutamide In Men With High-Risk, Hormone-Sensitive, Non-Metastatic Prostate Cancer That Has Recurred Following Definitive Local Therapy

I agree with Tony that we're likely to see some combinations next year. Sadly, many clinical trials that don't involve Big Pharma have been delayed by NIH cuts.

- Allen
Posted 11/1/2014 1:20 AM (GMT 0)
As far as cabozantinib, it failed COMET-1 trial, no survival benefit. The COMET-2 trial was stopped. But it is available off-label. Other trials continue.

prostatecancerinfolink.net/2014/09/02/cabozantinib-shows-no-survival-benefit-in-comet-1-trial/

Post Edited (robertC) : 10/31/2014 7:32:27 PM (GMT-6)

Posted 11/1/2014 5:06 AM (GMT 0)
Hi Caspar,
Xtandi is at this time in the final process of approval for use before chemotherapy. The FDA Advisory Panel did recommend pre-chemotherapy approval but it has not yet been relabeled. That said, I know a lot of guys that were able to get it before chemotherapy and get it approved through their insurance carriers as well.

www.medscape.com/viewarticle/831548

The approval process may have been completed, but until the label is complete some carriers are resisting. CTEP (ctep.cancer.org) is the federal group that helps with trial design and final relabeling. Once the FDA says go, sometimes it gets delayed but the PREVAIL trial was a success in showing survival such that the trial was ended early and approved to the final phases just last September.
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