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Halaven Approved For Metastatic Breast Cancer Treatment

By November 16, 2010

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Halaven (eribulin mesylate) has been approved by the FDA for metastatic breast cancer treatment.  Halaven is made by Eisai Inc. and can be used to treat late-stage breast cancer in patients who have already taken two previous chemo regimes.  If a metastatic breast cancer patient has already been treated with an anthracycline - such as Adriamycin, and a taxane - such as Taxol, they can qualify for treatment with Halaven.  This new drug is not a taxane, but is a synthetic version of halichondrin B, which occurs naturally in a marine sponge - Halichondria okadai.

Halaven passed a Phase 3 clinical trial called EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus Eribulin).  The EMBRACE trial showed that metastatic breast cancer patients who took Halaven lived an average of 2.5 months longer than those who were treated with a different drug chosen by their physician.  762 patients participated in the Halaven clinical trial.   "Many women with metastatic breast cancer see their disease progress after receiving multiple therapies," said Linda Vahdat, M.D., Professor of Medicine at the Iris Cantor Women's Health Center at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City. "Now, with the approval of Halaven, we can offer a new option that has been shown to improve survival in women with metastatic disease."

This new drug does come with a price - side effects of Halaven treatment include:  neutropenia, anemia, fatigue, hair loss, peripheral neuropathy, nausea and constipation.  Patients who tried Halaven but decided to stop taking this drug cited discomfort from peripheral neuropathy as their reason.  Other patients complained of severe fatigue or severe neutropenia - sometimes accompanied by fever.  Halaven has a small risk of causing irregular heartbeats, so heart patients who try this drug should be monitored.  For patients who have liver and/or kidney problems, a lower than average dose of Halaven should be used.

Halaven in made in Japan by Eisai Inc. and will not be available in the United States until around November 25, 2010.  If you qualify for Halaven treatment but need help paying for it, the company has a Patient Assistance Program you can call at 1-866-61-EISAI between 8 a.m. and 8 p.m. ET Monday through Friday.

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Comments
November 18, 2010 at 11:06 pm
(1) Marjorie says:

Thanks for sharing this.

The side effects of Halaven treatment include: neutropenia, anemia, fatigue, hair loss, peripheral neuropathy (severe enough to cause many trial participants to drop out), nausea and constipation not to mention possible irregular heatbeats. For a possible 2.5 month gain in overall survival, this seems a very dear price to pay in terms of quality of life.

Linda Vahdat, M.D.’s comment , “Now, with the approval of Halaven, we can offer a new option that has been shown to improve survival in women with metastatic disease.”

I do not view this as progress but sadly, more of the “same old same old”. Women with metastatic breast cancer need and deserve far better options than this.

November 19, 2010 at 10:34 am
(2) breastcancer says:

@Marjorie: There certainly are tradeoffs with treatment like this in buying 2.5 months of life with the cost of additional side effects – none of which are pleasant. I hope that oncologists clearly explain to metastatic patients what they can expect from Halaven treatment. For some, those extra months might be worth the pain. I can’t decide if I would take that road. But I do agree, metastatic patients need better treatments, with better quality of life, than yet another chemo drug that weights life down with those side effects.

November 29, 2010 at 12:36 am
(3) Jane says:

I am glad that another drug may bring some hope for breast cancer pt’s. I agree 2.5 mos. is not very long but it may be the world for someone who is trying to make it past a wedding, graduation etc.

Can anyone tell me the cost and availability of Halaven.

Thank you,

Jane

November 29, 2010 at 11:38 am
(4) breastcancer says:

You can find more info about Halaven from the drug company here http://www.eisai.com/section.asp?ID=287 Esai has patient assistance programs, too.

December 8, 2010 at 9:33 pm
(5) gay says:

I am glad that Eisai had discovered this new drug which could prolong a little bit of the life of cancer patients. You see, having cancer is too treatening.

December 29, 2010 at 3:39 pm
(6) Marge says:

I will start Halaven next week. I have been in treatment for 9 years. This last bout has lasted 3 1/2 years. It is currently in my bones and liver. The side effects don’t sound any different than any other chemo drug I have taken and beleive me I have been on them all.

I never consider myself terminal. So I am surprised by the comments above. I have been living with breast cancer for years and I have a pretty good quality of life.

I am disapointed that this chemo doesn’t sound any different that any others. When will a new approach be introduced?

January 26, 2011 at 4:06 pm
(7) KK says:

To Marjorie and many others…… I realize this study doesn’t show a huge improvement in life expectancy, but remember that as a new drug, it was only tested in women who were already very ill. In time, hopefully it will be used earlier during treatment for breast cancer and with better results. I agree, chemo is not a great way to fight a disease….. but sometimes it’s all we’ve got! I have heard reports that Halaven actually tends to be less toxic than some other chemo agents, but I don’t know what the data, if any, are.

All the best to those of you fighting BC.

March 31, 2011 at 6:59 pm
(8) Richard says:

My wife has had breast cancer for 13 years. She has used up all drug options and now we are faced with Halaven. Our son will be married in July and our daughter in December. We are contemplating using this drug. My wife has cancer in her bone marrow and is not good. Is this drug worth taking for her? The side effects sound gross. Also, we are in Australia and the cost is $5000 for one course which we believe is two weeks. Are there subsidies out there that can help us? It is not on the Pharmaceutical Benefit Scheme in Australia.

June 2, 2011 at 1:30 pm
(9) Pat Flores says:

I have been taking chemo for so long they ran out of options for me in May 2010. My doctor was ready to suggest hospice for me until she told me an new chemo (halaven) had been approved for advanced breast cancer. I just finished my 6th phase (2weeks on 1 week off) and had great reports from my PetScan. I am now starting on my new round. Hair loss is about the only side effect I have had. Food tastes good, my appetite is good … this is the best chemo I have ever taken (as far as side effects). My liver and stomach were so enlarged before I started on Halaven… now they are starting to shrink. Halaven has given me more than 2,5 months. I’m looking forward to many months. I’m 81 yrs. old.

August 9, 2011 at 12:12 am
(10) Jo Anne Trotta says:

I was told I had metastatic stage four cancer on 1/19/10 after 17 years since my lumpectomy, axillary dissection and radiation treatment. I was not feeling well for about four years and no one could get to the bottom of it.
Anyway after nine different hospitals. MD Anderson the number one rated hospital for cancer. Sloane Kettering and so on. For a year and a half I got different Chem. from different doctors and at different hospitals. I kept going because each time I was tested the cancer was progressing. Each time I had my CT scans to see if the treatment was working the cancer had gotten worse. I am now having to be connected to oxygen 24/7. Leaving the house has become quite an adventure as I MUST have tanks with me to last for how ever long I will be out. I have the cancer in my bones and liver.
MY POINT IS THE HALAVAN IS THE FIRST CHEMO THAT GAVE ME GOOD NEWS. I HAD MY CT SCANS LAST WEEK AND MY LUNG CANCER HAS IMPROVED. MY BONE AND LIVER CANCER HAS STAYED THE SAME…….WHICH TO ME IS AN IMPROVENT SINCE ALL THE OTHER TIMES THERE WERE NEGATIVE CHANGES. MORE CANCER EACH TIME. SO THE REPRORTS THAT YOU GET STATE YOU GET TWO AND A HALF MONTHS LONGER. I AM NOT SURE IF IT IS GIVING THE WHOLE PICTURE. EVERYONE WILL REACT DIFFERENTLY TO CHEMO AND I KNOW THAT THIS DOES NOT MEAN I AM CURED BUT IT SURE IS BETTER THEN THE FACT THAT ALL THE OTHER TREATMENTS WERE NOT HELPING AT ALL.
I WOULD LIKE TO SEE MORE NEW CHEMO OUT THERE TO TREAT WOMEN. SOME OF THE WOMEN I MEET ARE BEING TREATED WITH CHEMO MY AUNTS , MOTHER AND COUSIN USED OVER 30 YEARS AGO. I FEEL LIKE MORE RESEARCH SHOULD BE BEING DONE.

September 7, 2011 at 6:42 am
(11) Chris says:

Be glad you have some kind of chemo in supply. I am now starting Halaven today. I was on doxcil, but the company got a short supply, and oncologist’s are finding it hard to get any. It comes down to the mighty dollar as usual. Its bad enough im a man with a chicks disease, but now the chemo i was doing well on, has run out. Anyway, thats my story. Signing off….GODLESS.

September 13, 2011 at 4:14 pm
(12) Lainie says:

Do any of you know if this medicine has been known to cause hallucinations? My grandmother has been fighting breast cancer for 6 years now and her cancer has spread into both of her lungs. She started this drug after Doxil and has had 3 doses to this date. Recently she has reported seeing things that are not there and she becomes very upset and afraid. I have had to go and search her house because she swears that she saw someone walking through her front door. The door is always locked and there is never anyone there. I know this drug is fairly new so I just wondered if there was any information about side effects of this nature available.

September 18, 2011 at 11:37 am
(13) wendy says:

I am now on halaven after trying 13 other chemos. The halaven seems to have slowed down the growth of the cancer. I have had metastatic breast cancer for 8 years. It is in my bones and liver. This chemo has been very easy for me to tolerate. I only get 75% dose because the 100% knocks me down too much. I have outlived my prognosis by over a year already. Nobody but the good lord knows our expiration date. I thank the lord that this chemo has been found and works as well as it does.

October 28, 2011 at 2:47 pm
(14) theresa says:

I just lost my sister who fought and won breast cancer 10 years ago. March 2010 it was back in her bones,liver and fluid around lungs. We were told she had 6 months to 3 years. she was treated with avaistin,abarxen to start she was recieving triple doses because she was so strong. She seemed to be doing better according to scans. spot in liver was gone. fluid around lung was gone. She was tired and sometimes sick to her stomach, but thought she was going to get the 3 years. they started just avastin. We are a very close family who tell each other everything good or bad. June 2011 we were all together, she seemed a little weak but not to bad. When she returned to her home ( none of us live in same state) ct scan showed enlarged liver pushing on lung and stomach. Gem-zar was the next drug it took her down very quick. next was halaven. And this comes to my reason for writing the doctor kept telling us that the drug caused her throat to get ulcers so bad she could’nt swallow or breath. He put her in hospital and told us all she needed was fluids and antibotic to take down swelling. When her daughter asked if we should come she was told no need to. the day after she called we all got a message from her other daughter that things didn’t look so good. needless to say by the time family got to her she was semi -coma. We were told 24 to 48 hours. Some of us didn’t make it she lingered in extreme pain for 3 days. We couldn’t understand one day before she just needed antibotics. When we finally got a resident Dr. to ask he said didn’t they tell you that when you get to this drug survival is 1-2 %. that was never said to any of us. Even when we ask. So for anyone out there who is to the point of taking Halaven please make them answer the question we didn’t get the answer to until too late.

January 3, 2012 at 5:02 pm
(15) Ann says:

I have been fighting breast cancer that has spread to my liver and bones for 12 years. 12 years of continual treatment. I have handled all 8 different chemo treatments without many problems. In July 2011 I was given a high dose Halaven and became pretty ill. I was not hospitalized but was unable to do much for about a month. I had thrush of the mouth, headaches, neuropathy, nausea, hair loss, depression and extreme fatigue. However my ct scans were much improved even after the first couple of weeks. Because of the neuropathy and fatigue I decided to go off the Halaven and start another treatment. This treatment worked for a couple of months but then the cancer cells started to grow again. As of Wed I am back on Halaven, but a much smaller dose. I immediately got headaches and my depressions came back but nothing else yet. My dr. believes that the cancer cells are extremely sensitive to this medication and we are both looking forward to a much improved CT scan.

January 10, 2012 at 8:43 pm
(16) Bridget says:

Hi, I’ve been fighting stage IV breast cancer for the last 2 years. Hormonal therapy worked for about a year, but all my options have run out. I haven’t had good luck with chemo. I start Halaven this week, but after reading Theresas’s comment I’m a little nervous. I hope Halaven is not my last option! Are side effects as bad as they sound? I have a four year old to chase after and hope to find some light in this dark tunnel. I’m hoping for a few more years not 2 more months. Has anyone been on this drug for more than 6 months?

Thanks for your help!

March 6, 2012 at 3:12 pm
(17) Paul says:

I wouldn’t worry about what some resident says. I would listen to your oncologist. That 1-2% number is absolutely not true. So get it out of your thoughts!!! First of all, we all know that everyone’s body is different. Second, as far as an extra 3 months survival, that is a median number, and that’s with patients who entered into a trial because they were in an advanced state of metastasis, Basically, the end was near (very sorry to say) and nothing would stop the cancer unless it was a cure. So the fact that the median was an extra 3 months for them could translate into much more time for someone who is in a better situation i.e. less advanced mets.

Yes, I agree, more research. I have four kids and my wife is triple negative, you think I give a s—t about space exploration?
Spend the money on research!

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