HealingWell
Search Close Search
☰

Xtandi (enzalutamide) (formerly MDV3100) approved USA

Support Forums
>
Prostate Cancer
✚ New Topic ✚ Reply
❬ ❬ Previous Thread |Next Thread ❭ ❭
Posted 8/31/2012 7:01 PM (GMT 0)
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317838.htm

www.fiercebiotech.com/story/medivation-wins-groundbreaking-fda-ok-blockbuster-prostate-cancer-drug/2012-08-31

Approved 3 months ahead of schedule for post-chemo, hormone resistant patients

Post Edited (robertcool) : 8/31/2012 1:19:57 PM (GMT-6)

Posted 8/31/2012 7:36 PM (GMT 0)
So it is approved for anybody now?  Hope so, only thing I hate is the price tag and I thought Zytiga was a rip off for pills, this is 'super casodex' it has been called and I would consider taking it, sadly insurance company gets the shaft (currently anyway).   Just happens to be priced about equal to Provenge treatment for equal one year of therapy, just a coincidence. (lol)   Glad it is soon available.
Posted 8/31/2012 7:50 PM (GMT 0)
A. Approved for prostate cancer patients previously treated with docetaxel.
B. The FDA mentioned metastatic castration-resistant prostate cancer,
I suppose it will be used off-label with lesser conditions someday.
Posted 8/31/2012 7:58 PM (GMT 0)
Once the FDA approves it, I think anyone can use it off-label if a doctor prescribes it. However, insurance companies may not pay for it unless the use fits the FDA approval criteria.
Posted 8/31/2012 8:28 PM (GMT 0)
This is terrific! My husband is into his second month on this medication.
Posted 8/31/2012 9:12 PM (GMT 0)
Awesome news!
Posted 9/1/2012 3:46 AM (GMT 0)
Fabulous news!

Zimac
Posted 9/1/2012 8:52 AM (GMT 0)
Great, great news!!!!
Posted 9/1/2012 9:07 AM (GMT 0)
YEAH!!

Stupendous news! Yet another weapon for us Prostate Cancer Warriors!

HUGS ALL!

Bud

We will beat this crap!
Posted 9/1/2012 12:51 PM (GMT 0)
This made my morning, as it is undoubtably in my future. I think that southern comfort is right in that anyone can now use it if prescribed (even before chemo), but insurance may not cover it until after chemo failure. I will ask my oncologist next month, as he was already thinking about mdv3100 for me. But still awesome news, now let's extend out the additional 5 months of survival benefit!!!!!!
Posted 9/1/2012 2:56 PM (GMT 0)
You can read full prescribing information about Xtandi here:

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

Post Edited (HOPENEVERDIE) : 9/1/2012 10:07:50 AM (GMT-6)

Posted 9/1/2012 5:07 PM (GMT 0)
Here's the announcement from the New York Times, with some useful extra info.

According to an article in today's New York Times, the FDA yesterday gave early approval to MDV3100 (the brand name is Xtandi) from the company Medivation. The drug was proven to extend survival by five months for the median patient in late stage PC cases. Xtandi will cost $7,450 a month, Medivation said.

www.nytimes.com/2012/09/01/business/fda-approves-prostate-cancer-drug.html?_r=1

an excerpt:

"Xtandi is expected to compete most directly with Zytiga. Both are pills, while the other drugs are given intravenously. And both are aimed at the same patient population — men whose cancer has spread elsewhere in the body or recurred despite treatment aimed at suppressing production of the hormone testosterone, which fuels prostate cancer growth.

Both drugs are approved for men who have already tried docetaxel, though both Medivation and Johnson & Johnson hope to eventually win approval for their drugs to be used before docetaxel, a potentially much larger market. Many patients would prefer to use the pills before having to try chemotherapy...

Xtandi and Zytiga have not been compared head-to-head in a clinical trial. But some analysts say Xtandi would have an edge because it does not have to be given with prednisone, a steroid, to minimize side effects, as Zytiga does."
Posted 9/1/2012 5:12 PM (GMT 0)
This is indeed great great news......there are many of us who will need it. But at a cost of $7450 per month, who is ripping who off ? In most parts of the the country just 12 months of this would buy a small house. Kinda scary !
Posted 9/1/2012 6:03 PM (GMT 0)
Prescribing information: "Contraindications: pregnancy".

I just HAD to laugh!! How many prostate cancer patients can that POSSIBLY apply to??
Posted 9/3/2012 4:05 AM (GMT 0)
Sequoia ranger ,

it is not as stupid as it may sound because there is a stage 1 trial about to start or has started for the treatment of breast cancer in women. This initial trial is for about 40 women.
The are a number of other trials starting soon with MDV3100 for different stages of PC and patients.
We just hope that they will also be as successful as the "affirm" trial.
Posted 9/3/2012 5:08 AM (GMT 0)
Important note about Xtandi (MDV3100)
This drug has a very short patent life ~ well actually it has the same patent life as others but it was developed years ago and therefore it will be expensive since the chance to recoup costs before the patent expires is short ~ thus it is expensive...

But in short time it is scheduled to become generic unless the patent gets extended...

(as I've heard from an industry expert)

Tony
Posted 9/3/2012 1:50 PM (GMT 0)
Xtandi (enzalutamide) Approved as Treatment of Last Resort for Prostate Cancer

" Based on evidence that taking the medication prolonged survival for men whose prostate cancer had spread to other organs and not responded to previous chemotherapy and testosterone-blocking treatments, the U.S. Food and Drug Administration has approved Xtandi (enzalutamide) from Astellas Pharma and Medivation.

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.

Astellas and Medivation have created a patient information fact sheet pharmacists should distribute to and discuss with each man beginning treatment with Xtandi.

Again, the most important consideration for prescribing and dispensing Xtandi is that it is indicated only for men with metastatic prostate cancer tumors that will not stop growing despite courses of docetaxel (e.g., Taxotere from Sanofi-Aventis) or castration. The Xtandi regimen is relatively simple -- four 40 mg capsules taken once each day -- 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."

pharmacy.about.com/b/2012/09/01/xtandi-enzalutamide-approved-as-treatment-of-last-resort-for-prostate-cancer.htm
Posted 9/3/2012 8:22 PM (GMT 0)

TC-LasVegas said...

But in short time it is scheduled to become generic unless the patent gets extended...

(as I've heard from an industry expert)

Tony

I didn't find the info for MDV3100 but patent expiring is a very intersting topic expecially in relation to the crazy cost for these kind of drugs, eg the patent for Abiraterone will expire in 2014 ( see par.1.3
http://adisonline.com/drugsrd/Fulltext/2010/10040/Abiraterone_Acetate.7.aspx)
Posted 9/4/2012 12:03 AM (GMT 0)
LucaLuca,
This is of course a tribulation when a drug gets patented and then sits on the shelf for a lengthy period. The go to market costs don't change so the business model is complicated by short branding life by the folks that have to put the drugs through trials before release. This can drive costs up because the ability to recover the costs of release are quite short. As you point out, Zytiga is set to expire and go to generic soon. So 5K is the best they can do to recoup the go to market costs. JEVTANA expired this year and has been extended a year as they have not recouped the costs for the development and go to market trials for cabazitaxel. So it is now the generic has to wait a year.

Most do not realize that not all new release drugs are not recent patents.

I am getting conflicting web searched on MDV3100. MDV300 (MDV3100 is one in a series off that patent) patents were set out in 1995. I see one line saying that MDV3100 expires in 2027 and another in 2015. I would seriously doubt that the $7500.00 per month price for MDV3100 is necessary unless there are issues with the patent. my suspicion is that the makers are asking for the latter date.

Tony
Posted 9/4/2012 9:13 AM (GMT 0)
Tony,
according to the interesting Blair report Enzalutamide/XTANDI expires 2025, Abiraterone 2019:

http://www.williamblair.com/en/~/media/Downloads/Research/Transforming%20Time%20for%20Prostate%20Cancer%20Therapies.ashx

If Enzalutamide gets a FDA-GO for the pre-Chemo setting, than the cost situation will be very difficult, even for us in Europa, but much more for developing countries.
Posted 9/4/2012 1:01 PM (GMT 0)
I was trying to check out the patent yesterday on the web. What I found is that MDV3100 enzalutamide is based on an older medicine. about 2003/2004 scientists at UCLA reformulated the medicine to produce a more effective variant.
Medivation is worth over 3 billion dollars now so stock analysts are betting on a longer patent.
ARN-509 might be around in a couple of years so maybe there will be some competition.
Robert C

Post Edited (robertcool) : 9/4/2012 7:04:30 AM (GMT-6)

Posted 9/13/2012 2:04 PM (GMT 0)
Medivation and Astellas Announce XTANDI(R) (Enzalutamide) Is Now Available for Patients With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Docetaxel

SAN FRANCISCO, CA and TOKYO, Sep 13, 2012 (MARKETWIRE via COMTEX) -- Medivation, Inc. MDVN -0.41% and Astellas Pharma Inc. today announced the availability of XTANDI(R) (enzalutamide) capsules for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. XTANDI was approved by the U.S. Food and Drug Administration (FDA) on August 31, 2012. XTANDI is being distributed through a network of specialty pharmacies and specialty distributors.

Astellas and Medivation also announced the launch of a comprehensive patient access support program for XTANDI capsules to ensure patients who are prescribed XTANDI can access the drug in a timely manner. The new program, XTANDI Access Services(SM), will provide access and reimbursement support to physicians and patients and assist eligible patients without insurance. Examples of support available through this program include help with benefit verification and prior authorization, patient referral to independent non-profit organizations that can assist with out-of-pocket expenses, and prescription forwarding to specialty pharmacies in the network.

"It is our goal that this comprehensive set of services will help patients obtain access to XTANDI, regardless of their financial situation," said Mark Reisenauer, Vice President of Oncology Sales and Marketing, Astellas.

"We applaud the efforts that resulted in XTANDI becoming available to patients so quickly, and are pleased that a comprehensive access program is simultaneously available to help men and their physicians obtain this important new therapy," said Wendy Poage, president, Prostate Conditions Education Council.

XTANDI Access Services may be contacted Monday through Friday from 9:00 a.m. to 8:00 p.m. ET at 1-855-8XTANDI (1-855-898-2634) or by visiting www.XtandiAccess.com
Posted 1/29/2014 2:51 PM (GMT 0)
Here's the latest I've heard regarding Enzalutamide. Two points of note. First, this study indicates benefit if taken before chemo. Second, the MedPage Today article indicates additional benefit if taken with radiation treatment.

Enzalutamide May Prolong Lives, Delay Tumor Progression In Men With Advanced Prostate Cancer.

The New York Times (1/29, Pollack, Subscription Publication) reports that research indicated that “Xtandi [enzalutamide] prolonged lives and delayed tumor progression when used before chemotherapy in a study of men with advanced” prostate cancer. Investigators found that “the estimated median survival for the men who received Xtandi was 32.4 months after taking the drug compared with 30.2 months for those who received a placebo, a difference that was statistically significant.” The study also indicated that the medication “reduced the risk of the cancer worsening by 81 percent.” http://www.nytimes.com/2014/01/29/health/drug-shows-promise-in-advanced-prostate-cancer-when-used-before-chemotherapy.html?_r=0

        Reuters (1/29, Berkrot) reports that the findings were released yesterday, ahead of presentation at the American Society of Clinical Oncology Genitourinary Cancers Symposium. The findings may lead to an expanded approval for the medication. http://www.reuters.com/article/2014/01/28/us-medivation-prostate-idUSBREA0R1VE20140128

        HealthDay (1/29, Gordon) reports that the medication is already FDA-approved “for use in men with advanced prostate cancer who have received chemotherapy.” http://consumer.healthday.com/cancer-information-5/mis-cancer-news-102/drug-extends-survival-for-men-with-advanced-resistant-prostate-cancer-684296.html
        The Oncology Report (1/29, London) reports that the medication “was well tolerated and not associated with an increase in the rate of treatment discontinuation because of adverse events.” http://www.oncologypractice.com/oncologyreport/news/top-news/single-view/enzalutamide-improves-survival-in-chemo-naive-metastatic-prostate-cancer/f9e2ab74cb9209e280d396b942e8257d.html

        MedPage Today (1/29, Bankhead) reports on the enzalutamide study, and adds that “another study reported at the press briefing confirmed and extended results from a large randomized trial that compared life-long hormonal therapy with or without radiation therapy.” The “initial reports showed that the addition of radiation therapy was associated with a 50% improvement in 10-year survival in men with nonmetastatic advanced prostate cancer.” MedPage Today adds, “In an update of the results, Sophie D. Fossa, MD, PhD, of the Norwegian Radium Hospital in Oslo, reported that patients who received external-beam radiation therapy in addition to anti-androgen therapy had a prostate cancer-specific mortality of 12% at 15 years versus 31% for patients who received hormonal therapy alone.”
http://www.medpagetoday.com/MeetingCoverage/MGUCS/44024

Posted 1/29/2014 2:57 PM (GMT 0)
Thanks for updating new developments with Xtandi. These are the Prevail trial fiinal results.
Hopefully there will be an application for pre chemo prescribing soon.
Posted 12/28/2014 4:25 AM (GMT 0)
Xtandi hopefully works for some, I do hope so. That wasn't the case with my husband, he took it seven months of this year, his psa went down for the first 3 months, then back up sharply the 2nd 3 months.

He lost a huge amount of weight, felt very ill on it , it took away his appetite totally, it was a struggle. He is off it now and has weight gain.

Lets hope it works well for all of you
✚ New Topic ✚ Reply