Xtandi Approved

What exciting news. I'm currently doing well with Zytiga, but it's really nice to know that there's another arrow in the quiver.

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You can see full prescribing information for XTANDI here:

http://www.astellas.us/docs/us/12A005-ENZ-WPI.pdf

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Thanks Tony. It's currently only being approved for post chemo. It's only a matter of time before chemo naive treatment is approved.

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Does anybody have any idea what the time line is for the approval of Xtandi (MDV3100… the new name takes some getting used to) and/or Zytiga (abiraterone) for pre-chemo men. This is a huge market and there is currently nothing new and approved out there for men that are castrate resistent that does not involve significant side effects (chemo). So for most of them it is either go the chemo route or buy Zytiga off label (supposedly 30% of their current sales) and I guess now buying Xtandi off-label which is even pricier than Zytiga.

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Festinalente82, there is only one drug for castrate resistant patients before CHEMO, approved by FDA- PROVENGE ( immunnoterapy ).
The NCCN recommends PROVENGE as a first-line treatment and give Category 1A, the highest (NCCN Cat. 1 rating, the highest for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer ). A category 1 recommendation means that, “The recommendation is based on high level evidence (e.g., randomized controlled trials) and there is uniform NCCN consensus” about the recommendation". It is only drug that has Cat.1 rating for castrate resistant prostate cancer. 1 month treatment, almost no side effects.

ZYTIGA approved by FDA for use AFTER CHEMO. The NCCN give Category 2B . Per NCCN guidelines, "use of Zytiga as secondary hormone therapy for treatment of patients with no or minimal symptoms who are not candidates for docetaxel-based regimens is a category 2B recommendation.Zytiga has not demonstrated a prolongation in overall survival in the pre-chemotherapy setting." 8-12 month treatment (after CHEMO), 14-18 month treatment (before CHEMO), significant side effects.

XTANDI (MDV3100) approved for use AFTER CHEMO. The NCCN doesn't give yet Category ( I think it will be like ZYTIGA Category2B). 8-12 month treatment (after CHEMO),14-18 month ( similar to ZYTIGA BEFORE CHEMO), significant side effects.

Now many prominent doctors talk about sequences treatment for castrate resistent patients They recommend start with PROVENGE and after move to other treatment. You can find it here:

http://www.patientpower.info/video/asco-update-promising-treatment-sequence s-for-advanced-prostate-cancer

http://www.patientpower.info/video/advanced-prostate-cancer-novel-agents-fr om-asco-sequencing-and-combinations

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Tony19, Provenge is not yet available in Europe where we live. It is not yet approved by European bodies nor is there a manufacturing facility. There may be a feasibility study at some point, but we have been hearing about that for over a year from our doctors in the Netherlands. Problems with Dendreon have slowed that process. Provenge will always be a sticky point in Europe since insurance companies & national health services are significantly more reserved about costly drugs than their US counterparts.
So for castrate resistent metastatic PCa patients in Europe the only option at the moment is chemo, off label use of zytiga or one of the older 2nd line hormonal therapies such as ketocozonale or estrogens.
By the way the word on the street from the many I have heard from on Zytiga or Xtandi is that the side effects are minimal.

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I've beenn on Zytiga,(off label use, since I'm Hormone Resistant but chemo naive) and Prednisone for over a year. The side effects are minimal. The usual hot flashes and night sweats. I'm quite used to them. Still taking Lupron for a complete blockade. After "radio-surgery" in January, my PSA has gone from 21 to 1.3.

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Provenge expect to be approved in Europe in the first half of 2013 .

Provenge price in line with other drugs or even chipper:

PROVENGE- 93,000 $ ( 3 infusion during 1 month, almost no side effects );
The latest data indicate 75% of PROVENGE patients have no out-of-pocket expenses. If your household is less then 160000/per year, you don't pay you 20% copayment and it will cost you 0 $ in the USA.

ZYTIGA-44,000 $( ADT prostate cancer ; approved AFTER CHEMO 8 month treatment , 5500 per month ,+ add cost PREDNISONE + can be additional cost for treating side effect), according ABSTRACT from ASCO2012 a cost of $102,600/LY and of $129,000/QALY :
www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confid=114& abstractid=92306
ZYTIGA if approved by FDA BEFORE CHEMO -pay for a treatment based on a long (18-month) delay for OS curve separation ; Fifteen (15) cycles of ZYTIGA costs more than $82,425 there is no indication of a survival benefit for at least 18 months following the initiation of treatment. In the case of the ZYTIGA Phase 3 trial, 20% of the patients on ZYTIGA died before the curves separated + cost PREDNISONE +can be additional cost for side effects:
http://files.shareholder.com/downloads/JNJ/1743426414x0x573498/d69d9c36-61a 7-4fb7-927a-fb7c802f3b31/FINAL%20%3Cstrong%3E%3C/strong%3EZYTIGA%20%3Cstron g%3E%3C/strong%3EWebcast%20%3Cstrong%3E%3C/strong%3EUpdate%20%3Cstrong%3E%3 C/strong%3E5-31-2012.pdf
if the patient is on Medicare (USA), he can hit the 'donut' hole twice during his ZYTIGA dosage BEFORE CHEMO

XTANDI - 89,400 $ ( ADT prostate cancer; approved AFTER CHEMO 8-12 month treatment, 7,450 per month+ can be additional cost for treating side effect).
If this drug will prescribe by doctors BEFORE CHEMO (it can happened like with ZYTIGA) than treatment can be as long as 15-18 month then it can cost 111,750 $-134,100 $ .
If the patient is on Medicare (USA), he can hit the 'donut' hole twice during his XTANDI dosage BEFORE CHEMO

Side effects for XTANDI:
"Prescribing information for Xtandi notes that almost half of the men who took the new chemo drug experienced a serious side effects, ranging from seizures to joint pain, severe nausea, diarrhea, respiratory infections and blood in their urine (i.e., hematuria). Xtandi also has a high potential for adverse drug-drug interaction.
...but the frequent occurrence of serious treatment-related problems should merit regular assessment of the patient's experience and willingness to continue taking the drug.
Xtandi should become available in the United States by mid-September. European regulators are reviewing the drug's application."
http://pharmacy.about.com/b/2012/09/01/xtandi-enzalutamide-approved-as-trea tment-of-last-resort-for-prostate-cancer.htm

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I know I am not going to make any friends saying this, but sometimes when I read posts on this site I have the feeling that people are trying to further some sort of personal agenda. There is no magic bullet in PCa given that each person's cancer has so many specific characteristics some which we understand (PSA, gleason scores, and other markers) and some which we do not yet understand. This is why some men respond very well to certain drugs and can go into permanent remission whilst others with seemingly similar characteristics continue a downward trend with the same drug. I am not the first to say that timing and sequencing of PCa treatments is in many ways still an art and there is still so much we (the medical profession) do not know.
I just don't like the feeling that people are pushing a specific treatment as if it will work for everyone, that is just not reality and is a bit patronizing if you ask me.
The strength of these support groups is in sharing information, tips and insights as well as supporting each other through the financial and emotional roller coaster this disease puts men and their families on.
So shoot if you like, but this is something that i have been wanting to say for some time.

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Dear Festinalente82,

I agree with you. I am a pharmacist with prostate cancer that is offended by drug companies or investors pushing agendas on these types of forums. One of the Provenge pushers here is posting under a different name on another prostate cancer site. Exact same information.
Only Dendreon's drug (Provenge), uses this strategy. I believe Provenge has a niche for treating prostate cancer. It is unfortunate that the message is getting lost to some because of questionable motives.

Paul

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Nobody is pushing the agenda. Questing is about using all medicine in sequencing treatment. And no only just seaquensing treatment but RIGHT ORDER of sequencing that can maximum benefit patient . I read a lot on this board that people use PROVENGE like last resort or skip this treatment and it is too late for them benefit from this drug and other drugs . Goal for any patient learn all information , look for second doctors opinion and choice right treatment for them .

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I agree that some postings push certain methods of treatment. The decisions about sequencing and which drug regimen is best should be left to the individual patient and their doctor. Also, one persons experience is not going to predict another's experience. If there are postings coming from investors there should be disclosure of that fact.

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Accolades to Austinann !

Simply stated and right to the point.
There are numerous variables with PCa and no magic formula that has universal application.
...and if personal agendas or investor postings are relative, then disclosures for same should be disclosed.

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