MPIP: Melanoma Patients Information Page

The MPIP is the oldest and largest community of people affected by melanoma hosted through the Melanoma Research Foundation. It is designed to provide support and information to caregivers, patients, family and friends. Once you have been touched by melanoma—either as a patient or as a family member or friend of a patient—you become part of a community. It is not a community anyone joins willingly. But if you must be part of this group, you will find no better place to find the tools you need in your journey with this cancer, and the friends who can make that journey more bearable.

The information on the bulletin board is open and accessible to everyone. To add a new topic or to post a reply, you must be a registered user. Please note that you will be able to post both topics and replies anonymously even though you are logged in. All posts must abide by MRF posting policies.

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Gene_S's picture
Replies 2
Last reply 2/21/2012 - 8:31pm
Replies by: Gene_S, Anonymous

Vemurafenib for Melanoma Approved in Europe

Zosia Chustecka  

 Posted: 02/20/2012

February 20, 2012 — The oral targeted agent vemurafenib (Zelboraf, Roche/Plexxikon) has been approved in Europe for use in the treatment of patients with advanced melanoma whose tumors have a BRAF mutation. The approval was widely expected after the product received a positive recommendation in December 2011 from the European Committee for Medical Products for Human Use.

About 50% of patients with melanoma have this BRAF mutation. A companion diagnostic test, the cobas 4800 BRAF V600 Mutation Test (Roche Molecular Systems), is already commercially available.

Vemurafenib is already available in the United States, where it was approved in August 2011. It is also approved in Brazil, Canada, Israel, New Zealand, and Switzerland. Approval applications are under review in Australia, India, Mexico, and other countries, according to a Plexxikon press release.

Significant Improvement in Survival

The approval was based on a pivotal phase 3 trial (known as BRIM-3) published last year (N Engl J Med. 2011;364:2507-2516), which showed a significant improvement in overall survival.

This trial was conducted in 675 patients with previously untreated unresectable or metastatic melanoma, who had all tested positive for the BRAF mutation. Patients were randomized to receive vemurafenib or standard treatment with dacarbazine.

The trial was halted early because of "compelling efficacy data," according to a Plexxikon statement. Vemurafenib reduced the risk for death by 63% (hazard ratio, 0.37; P < .0001).

A post hoc analysis showed that vemurafenib significantly improved median survival, compared with dacarbazine (13.2 vs 9.6 months). Historically, patients with metastatic melanoma have had a median survival of 6 to 10 months, the company noted.

The safety information about vemurafenib notes that the drug can cause a type of skin cancer — cutaneous squamous cell carcinoma; this adverse event has been previously reported by Medscape Medical News. The labeling for the product urges patients on the drug to check their skin and tell doctors about skin changes, including a new wart, a skin sore, a reddish bump that bleeds or does not heal, or a mole that changes size or color. In addition, patients on the drug should avoid the sun, and cover up when they are outside during the day.

Potential adverse events include severe allergic reactions, severe skin reactions, cardiac events such as QT prolongation (which can be potentially life-threatening), abnormal liver function tests, eye problems, and new melanoma lesions.

Common adverse effects include joint pain, rash, hair loss, tiredness, sunburn or sun sensitivity, nausea, itching, and warts.

© 2012 
Medscape Medical News © WebMD, LLC
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Send comments and news tips to news@medscape.net.

Live 4 today. Thank God for all he has done for us. Looking forward to enjoying tomorrow.

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My Mother is Braf negative as well as C-kit negative. She has mucosal melanoma. She just started a reinduction of Yervoy and has her second treatment tomorrow. We are seeing a melanoma specialist in Miami, FL - Dr. Jose Lutsky. My Mom is going on 3 years with this melanoma. Here is a little about her history.

 

History:  69 yrs old - Primary vulva melanoma braf negative, c-kit negative and negative for ny-eso-1

Yervoy first round stable for 9 month. Recent recurance and moved to spleen.

10/17/2011 large FDG avid  mass gastric antrum 34x36 mm suv=8.6, FDG localization nodule lateral left mid lung pleural based 12mm suv=8.6, at least 4 left lung nodules only the largest of which is fdg avid

1/16/2012  gastric antrum 46x45mm suv=10.5, lateral apect spleen isodense 31mm suv=6.4 w/multiple persispnin hilar nodes 28mm suv=9.6 and 11mm suv=5.1, active pleural base nodule lateral left lung lingula 25mm suv=17.3, adjacent satellite 10mm suv=3.1, large left upper quadrant mass 44x34mm suv=14.0 brain mri - clear

Being that she is beaf and c-kit negative would she be negative for HLA2 or NARS mutations? She I push to have her tested? I need help with a plan B and C. Other then melanoma she is in good shape. Should we look into TIL for her? Take her to Moffitt or Sloan. Any advise would be greatly appreciated.

Thank you!

Wendy

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AlanM's picture
Replies 3
Last reply 2/21/2012 - 5:43pm
Replies by: Janner, AlanM, Karin L

Prior to interferon induction I did not have any ringing in my ears. Since the induction and 1 month of low dose treatment in the fall of 2010 the ringing has not stopped. I stopped the low dose part of the treatment due to retina damage. Curious if others have had this side effect and if so, did it ever go away? Very distracting......Is there anything to do about it other than just suck it up and live with it?

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Hi everyone, I found this web page and have been doing some research.  I am finding all the info confusing.  But one thing I do know is that I am going to be proactive about this.

I was told 2 days ago that I have Malignant Melanoma.  I didn't even get given a copy of my pathology results of the mole that was cut out of my back.  I did see a surgeon yesterday and asked him if I could see it.  The only info I took in was that it was 1mm and Clark level IV.  I have surgery scheduled for tomorrow to cut out 1cm each side of where the mole was.  I also wasn't given a 'stage' like I see so many other people have been given. 

The surgeon says that is all that should be needed and that I have a 15% chance it could return.  Doesn't really sound that great to me, especially when I have a 4 year old and a 1 year old that are the most precious things to me and no way could I stand it if I thought someone else was going to raise them..  No one could love them as much as me and their father couldn't look after them as well as I could lol (I lost my father young and I don't wish that on anyone). 

I do remember getting a swollen gland under my armpit recently that took a week or two to go down.  Could this be related?  My friend recently went to the doctor with swollen glands and a doctor took a mole out from her in case it was related (which it wasn't lucky for her).

What else can I do to be proactive about this.  I am starting with diet, lots of fruit and veg and am now officially a non-drinker. Any advice appreciated.

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There were posts that Steven O'Day will resume working, but not in the Angeles Clinic, but for months no one gave any update. Does anyone know what happened to Dr. O'Day and whether he is back to work anywhere?

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annem's picture
Replies 4
Last reply 2/21/2012 - 12:47pm
Replies by: dearfoam, KRob, Ali, LynnLuc

I recently posted about my husband, dx stage iv in 1998.  He began to lose weight and complain of headaches about 6 weeks ago.  Had MRI two weeks ago and his oncologist and neurosurgeon diagnosed pacymeningeal metastatic disease.  Neuro asked about taking him back to MD Anderson but I have decided not to do that.  He has been fighting this disease off and on for 14 years.  He had a stroke about a year ago and also suffers from radiation induced dementia from the whole brain radiation done on the initial brain tumor in '98.  The doctors have suggested hospice.  Has anyone had any experience with this diagnosis?   His oncologist has told me that the normal course of the disease is about 3 months and that my husband will probably have another massive stroke.  It is all overwhelming but I do not want him in pain.  Right now he is pretty much the way he has been since the stroke.  Some good days and some not so good.  He is fairly lucid in the mornings but the stroke left him unable to talk or walk without a walker.  Thanks for any info anyone has about this diagnosis.  Anne M, caretake to husband, stage iv

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Anonymous's picture
Anonymous
Replies 5
Last reply 2/21/2012 - 11:47am

Were you told benign mole or minimally atypical and turned out it was actually malignant?  VERY frustrated.

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Abachert's picture
Replies 6
Last reply 2/21/2012 - 8:01am

So I'm not truly a single mom, but my husband works with a collegiate football team which means during the season I basically am because he's at work for 14-17 hours a day and with the new coach, his hours have stayed like this even when they are not in season. We have a 2 year old daughter and I work full time as a sales manager for a hotel. Im stage 3A and we are debating if interferon is what is best for me and the family. I wanted to hear from single parents or families with young children on why you chose to undergo treatment and how it affected family life. Also, for those that are done with treatments, how long did side effects last after you finished and have there been any other issues that have come from doing the interferon? Thanks for the help! I want to be healthy but if they got all the cancer through surgery, is the interferon worth it?

Life is an occasion, rise to it!

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SStamps's picture
Replies 1
Last reply 2/20/2012 - 11:12pm
Replies by: Ali

Had scans done last week brain, lung, spine and leptomeningeal show improvement , but tumor on rib has grown so the Dr wants to start Braf he also said he may reintroduce the ipi. We have use special pharmacy the insurance company works with to get the Braf so we are waiting.   Mickey has been unable to drive since starting the IL2 treatment for the spinal fluid so he spoke with Dr about this the Dr ordered a EEG and Mickey still can't drive. He is bummed about the news but accepting.  His short term memory is off some, a word comes out wrong some and he can't drive because they are afraid he could have a seizure, but besides that he is doing good.  It has almost been a year since the pathology confirmed Stage 4 melanoma.  I feel very bless to have this time with my husband :)

Samantha

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James from Sydney's picture
Replies 2
Last reply 2/20/2012 - 10:33pm
Replies by: Mike N, jim Breitfeller

For those of you down under we are organising our inaugural Melanoma walk on March 25 to raise funds for The Melanoma Institute of Australia. They intend to map the entire Melanoma Genome from the largest tissue bank in the world, held at the Institute, they hope to identify all possible Mutations. 

melanomamarch.com.au is the site to register to walk and if you like set up a fundraising page. Melanoma is now the most common Cancer in Australia in the 15 to 44 year age group.

best wishes 

James

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bruski1959's picture
Replies 6
Last reply 2/20/2012 - 8:25pm

The Yervoy was shipped via Fedex and arrived at the hospital this morning by 10:30 AM. Pastor's wife Virgie took Jackie for her appointment. They took an x-ray of her port, and they will do that before every infusion apparently. My class in Schaumburg, IL got out at noon, so I got to the cancer center a little after 1 PM, and was able to relieve Virgie. They gave Jackie benadryl and a couple of anti-nausea medications prior to the Yervoy, and then transfused the Yervoy for 90 minutes, following by a flush. So we got Jackie home a little after 3 PM from her noon appointment. The benadryl made her sleepy, so she rested when we go home. So far there doesn't seem to have been any side effects, but we will keep an eye out for them.

Jackie's next infusion is scheduled for 2/24. Jackie goes back to the Cancer Center every Wednesday for blood tests.

 

We're glad to have have finally gotten Jackie started on the Yervoy treatment. We're praying that Jackie tolerates the treatment well, that the Yervoy slows down the melanoma, and shrinks the melanoma tumors.

 

Thanks for your thoughts and prayers!

 

Bruce and Jackie

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himynameiskevin's picture
Replies 12
Last reply 2/20/2012 - 3:29pm

Well the most recent CT scan show the tumors in my lungs are still progressing since my last scan on Jan 9th. Some at faster, more alarming rates, and some not so much. Not the news I was hoping for, but, it is what it is, just another little speed bump. I’m in a tricky spot right now. On one hand, as unlikely as it seems, I guess the Yervoy could essentially still kick in any minute, it's been 2 months since my final dose. On the other hand, things are getting worse, and waiting for something that’s unlikely and may not happen may not be in my best interest. Some would say wait it out, some would say move on, and they are.

As suggested by both of my oncologists, before finalizing a decision to wait it out or go with zelboraf, I spent the last 3 days getting every bit of attainable information (disks, written reports, lab notes) of all recent treatments and medical history together and contacted my most recent doctor and team at the National Institute of Health with a brief update of what has been going on, in hopes that maybe they’ll have a trial or an idea we could both benefit from. Maybe they could hit me with the ACT again, as intense as it was, I would love another shot. Or maybe they've got something new to try, something I'd seem like a good candidate for. She agreed to look them over, discuss any options with the team and get back to me. Personally the thought of going back there, just makes my heart warm. At this exact time last year, I was on the mend because of their help, I remember the feeling, and the thought of possibly feeling like that again is... well it makes me smile, a true smile of unabashed happiness and hope. I know the chances of them accepting me for something aren't that great, but with all my history there, and a bit of much needed luck, maybe they will. We'll see. I fed-exed everything yesterday at the fastest rate possible, and hope to hear from them early this week. As always, this waiting in uncertainty is the hardest part, but I’ll be ok.

On a lighter note, I still feel fine, no pain, trouble breathing, nothing too abnormal from what I can tell. Of course there's some anxiety and nervousness, but during times like these I'm sure it's a pretty normal human reaction and will pass as soon as a plan is in course. 

Hopefully I'll have a plan and something beneficial to look forward to in the coming days. Until then, thank you all for the ongoing support and help though these stressful times. It means so much.

I'll talk to you soon.
-Kevin

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Lisa13's picture
Replies 6
Last reply 2/20/2012 - 2:38pm
Replies by: Maxximom, kylez, Anonymous, boot2aboot, LynnLuc, WendyPam

I'm starting ipi again on Friday - has anyone heard of the percentage of numbers for reinduction?  I've heard they're better used by responders, but I just have no idea.  There seems to be many different numbers, so it's hard to understand what it could be.  Half the time, I can't understand why a medicine wouldn't work if it worked before, but nobody seems to know this clinical drug very well.

Also, where in the U.S. are they having the cinical trial for Anti PD1 - Bristol Meyers? Apparently this one has been doing very well, but there isn't alot of these out there.  So confusing!  In Canada, we'll have Anti PD-1 (Merck) in 2 months, but I'm not even sure if this is going to be as good. 

One last thing, my Dr talked about a new clinical trial for brain mets coming available, so when I here about this, I'll be letting you all know.

Lisa

Many impossible things have been accomplished for those who refuse to quit

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Kellie-T's picture
Replies 2
Last reply 2/20/2012 - 1:46pm
Replies by: Kellie-T, aldakota22

Anyone taking Zelboraf get chills? I disn't see that one on the list of side effects.

Life is not by accident. Make every minute count.

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Feb. 20, 2012 06:00 UTC

Plexxikon Announces European Approval of Zelboraf® for the Treatment of Patients With BRAF Mutation-Positive Metastatic Melanoma

BERKELEY, Calif.--(BUSINESS WIRE)-- Plexxikon Inc., a member of Daiichi Sankyo Group, today announced that the European Commission has approved Zelboraf® (vemurafenib) for the monotherapy treatment of adult patients with BRAFV600 mutation-positive unresectable or metastatic melanoma. The cobas 4800 BRAF V600 Mutation Test, a companion diagnostic used to identify patients with the BRAF mutation, is CE marked and commercially available in Europe. Zelboraf is designed to selectively inhibit the BRAF mutation that occurs in about half of all cases of melanoma.

Zelboraf and its companion diagnostic have already been approved in the United States, Switzerland, Israel, Brazil, New Zealand and Canada. In the United States, Zelboraf is being co-promoted by Daiichi Sankyo, Inc. and Genentech, a member of the Roche Group. Roche promotes Zelboraf outside of the United States.

“The approval of Zelboraf by the European Commission marks a significant advancement for European patients with metastatic melanoma who historically have had very limited treatment options,” said K. Peter Hirth, Ph.D., chief executive officer of Plexxikon. “We are very pleased that our strategy to co-develop Zelboraf along with a companion diagnostic helped accelerate the availability of this personalized medicine for these patients.”

BRIM3

BRIM3, a global, randomized, open-label, controlled, multicenter, Phase 3 study, compared Zelboraf to dacarbazine (chemotherapy), in 675 patients with previously untreated BRAFV600E mutation-positive, unresectable (inoperable) or metastatic melanoma. The endpoints for BRIM3 were overall survival (OS) and investigator-assessed progression-free survival (PFS). Other endpoints included confirmed investigator-assessed overall response rate.

In January 2011, the data safety monitoring board for BRIM3 recommended termination of the BRIM3 study due to compelling efficacy data, and further recommended that study patients receiving chemotherapy have the option to cross over to the vemurafenib treatment arm.

  • The pre-specified interim analysis of BRIM3 showed the risk of death was reduced by 63 percent for patients who received Zelboraf compared to those who received standard first-line treatment (hazard ratio [HR]=0.37, p<0.0001).
  • In a post-hoc analysis of BRIM3 data with a longer follow up compared to previous analyses, including cross-over of patients from the chemotherapy treatment arm to the Zelboraf treatment arm, Zelboraf significantly improved survival by providing a median overall survival of 13.2 months compared to 9.6 months for those who received chemotherapy. Historically, patients with metastatic melanoma have had a median survival of six to 10 months. This analysis showed the risk of death was reduced by 38 percent for patients who received Zelboraf compared to those who received chemotherapy (hazard ratio [HR]=0.62, p<0.0001).
  • At 12 months, 55% of patients who received Zelboraf were alive, as compared to 43% of patients who received chemotherapy.

In the single arm BRIM2 study of previously treated patients, Zelboraf treatment also showed a survival benefit compared to historical control data. These data are expected to publish shortly.

Marketing authorization submissions for Zelboraf are currently under review by health authorities in Australia, India, Mexico and other countries worldwide.

Important Safety Information about Zelboraf (vemurafenib)

This information does not take the place of the patient talking to his or her doctor about their medical condition or their treatment with Zelboraf.

Zelboraf is a prescription medicine used to treat a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene.

Zelboraf may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC), that usually does not spread to other parts of the body. Patients should check their skin and tell their doctor about skin changes including a new wart, a skin sore or reddish bump that bleeds or does not heal, or a mole that changes size or color.

While taking Zelboraf, patients should avoid going out in the sun. When patients go outside, they should wear clothes that protect their skin, including head, face, hands, arms and legs. They should use lip balm and a broad-spectrum UVA/UVB sunscreen with SPF 30 or higher.

Possible serious side effects of Zelboraf include severe allergic reactions; severe skin reactions; changes in the electrical activity of the heart called QT prolongation, which can potentially be life-threatening; abnormal liver function tests; eye problems; or new melanoma lesions.

Common side effects of Zelboraf include joint pain, rash, hair loss, tiredness, sunburn or sun sensitivity, nausea, itching or warts.

These are not all of the possible side effects of Zelboraf. Patients must tell their doctor if they have any side effect that bothers them or does not go away. For more information about side effects, patients should ask their doctor or pharmacist.

Patients should call their doctor for medical advice about any side effects. Patients or their caregivers are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. They may also report side effects to Genentech at 1-888-835-2555.

Patients should read the Zelboraf full Prescribing Information and Medication Guide for additional important safety information at www.zelboraf.com.

About Zelboraf (vemurafenib)

Vemurafenib is a novel, oral small molecule, which was approved by the FDA in August 2011 and is being marketed in the U.S. as Zelboraf for the treatment of patients with BRAFV600E mutation-positive inoperable or metastatic melanoma as detected by an FDA-approved test. Zelboraf also has been approved by the European Commission, and in Switzerland, Israel, Brazil, New Zealand and Canada. Zelboraf is not recommended for use in melanoma patients who lack the BRAFV600 mutation. Plexxikon utilized its structure-guided chemistry platform to discover vemurafenib, and initiated clinical development in 2006. Shortly thereafter, Plexxikon and Roche signed a collaboration agreement to co-develop vemurafenib.

The cobas 4800 BRAF V600 Mutation Test, a DNA-based companion diagnostic used to identify patients whose tumors carry the BRAF mutation, was simultaneously approved in the U.S., and is CE marked and commercially available in Europe. Roche Molecular Diagnostics developed the cobas 4800 BRAF V600 Mutation Test following a 2005 agreement with Plexxikon.

Studies of vemurafenib in combination with other approved and investigational medicines as well as in other tumor types are being conducted. More information about ongoing vemurafenib studies is available at www.clinicaltrials.gov (in the U.S.) or www.clinicaltrialregister.eu or on the Roche Clinical Trials Registry at www.roche-trials.com (in the EU). Genentech can also be contacted by calling the company’s clinical trial call center at 1-888-662-6728 or emailing Genentech@druginfo.com.

About Melanoma and BRAF mutation

Melanoma is the most serious type of skin cancer and is growing at a rate of about five to six percent annually. More than 75,000 people in the U.S. and 160,000 people worldwide are diagnosed with melanoma each year. It is one of the deadliest cancers, with a five-year survival rate of 15 to 20 percent for people with advanced (Stage IV) melanoma, according to the American Cancer Society.

Risk factors for melanoma include a positive family history of melanoma, prior melanoma, multiple clinically atypical moles or dysplastic nevi, inherited genetic mutations, fair skin and sun exposure. However, melanoma can occur in any ethnic group and also in areas of the body without substantial exposure to the sun.

The BRAF gene is a key component of a pathway involved in normal cell growth and survival. BRAF mutations may lead to uncontrolled cell growth, and are thought to occur in about half of all cases of melanoma and eight percent of all solid tumors.

About Plexxikon

Plexxikon, a member of Daiichi Sankyo Group, is a leader in the structure-guided discovery and development of novel small molecule pharmaceuticals to treat human disease. The company’s lead drug Zelboraf (vemurafenib/PLX4032) was approved by the FDA in August 2011, and is being co-promoted in the U.S. by Daiichi Sankyo Inc. and Genentech. The company is developing a portfolio of clinical and preclinical stage compounds to address significant unmet medical needs in oncology, as well as in several other therapeutic indications. Plexxikon’s Scaffold-Based Drug DiscoveryTM platform integrates multiple state-of-the-art technologies, including structural screening as a key component that provides a significant competitive advantage over other drug discovery approaches.

 

Contacts

Plexxikon Inc.
Kathleen Sereda Glaub, +1-510-647-4009
President
kglaub@plexxikon.com
or
For Plexxikon
Susan Kinkead, +1-415-751-3611
susan@kinkeadcomm.com
or
Jennifer Cook Williams, +1-360-668-3701
jennifer@cwcomm.org

 

Source: Plexxikon Inc.

 

View this news release online at:
http://www.businesswire.com/news/home/20120219005025/en

Advocate for your own treatment.. Stage 4 Melanoma NED Surgery,Radiation, Temodar 300Mg July 2009-March 2010, then Thorocotomy...now "Phase I Study of Anti-PD-1 Human Monoclonal Antibody MDX-1106 and Vaccine Therapy"

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