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Arnie’s Rebounding World: Compassionate Use

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Published: Feb 12, 2014 2:43 pm; Updated: Feb 14, 2014 2:30 pm

I took off from writing my column in January while under­going treat­ment and try­ing to sort through other treatment options.

Since my donor (allogeneic) stem cell transplant in August 2012, my multiple myeloma had recurred again with aggressive extramedullary disease (myeloma outside of the blood and bone marrow).

This progression occurred despite several cycles of a regimen of Kyprolis (car­filzomib), Pomalyst (pomalidomide, Imnovid), cyclophosphamide (Cy­toxan), and dexamethasone (Decadron), leaving me in a very bad situ­a­tion.

Fortunately, my disease responded to a couple of cycles of high-dose chemotherapy with Velcade (bortezomib), thalidomide (Thalomid), and dexa­methasone plus cisplatin, doxo­rubicin (Adriamycin), cyclophosphamide, and etoposide (known as VTD-PACE).

The question now is what to do next?

I have exhausted all of the standard approved multiple myeloma drugs many times over.  What does a multiple myeloma patient do when all conventional treatments have failed?

Since I do respond, at least for now, to more traditional high-dose chemotherapy, some type of “main­te­nance chemo” regimen has been discussed; I am not sure what that would look like yet, though.

Another option is off label use of a drug currently approved for other cancers.  There are a few drugs ap­proved for other cancers that may be effective in multiple myeloma.

For example, based on genetic testing, a small percentage of multiple myeloma patients have the BRAF mu­tation found in malignant melanoma and may respond to a drug currently approved for that cancer. I have had the genetic testing done, but that’s a whole other discussion.

The other obvious option is an investigational drug.  By far the easiest way to get access to an investi­ga­tion­al drug is to enter into a clinical trial.

There are a few problems with that from my standpoint.

The main one is that all clinical trials have specific inclusion and exclusion criteria.  My specific cir­cum­stances – particularly my having had a donor transplant and having nonsecretory disease – exclude me from almost all trials.

The potential to be randomized to receive treatment not including the investigational drug, and the inflexibility to combine the investigational drug with other drugs not included in the study, are other problems.

Whenever I write a column like this, people always respond with suggestions about what to try.  It’s not that I don’t appreciate it, but, believe me, I’ve looked.  I don’t think there is too much out there that I haven’t re­searched or looked into.

The other option for obtaining an investigational drug outside of a clinical trial is through a program called “compassionate use.”  There is no Dallas Buyers Club for unapproved multiple myeloma drugs that I know of.

First a little background.

In 1938, the U.S. Food and Drug Administration (FDA) was given the authority to oversee the safety of drugs in this country and to prevent unapproved drugs from entering interstate commerce. Under FDA regulations, drug companies must obtain approval for any investigational new drug before beginning human testing.  The company must tightly limit and monitor patients who use the drug, usually under a clinical trial.

Over the last two decades, the FDA has allowed companies under certain circumstances to expand access to investigational drugs to individual patients outside a clinical trial through the “compassionate use exemption.”

The patient’s doctor must apply to the drug company for the drug and agree to monitor its use.

The patient must have advance disease, have failed standard treatment, not be eligible for a clinical trial, have no other treatment options, and have some expectation of the drug working with the benefits out­weigh­ing the risks.

Sounds like me.

There are few important things to know about getting a compassionate use exemption.  First, it is a long, sometimes daunting, process. Most importantly, and often misunderstood, is that this is not primarily an FDA decision.  It is up to the individual drug company to decide if they want to allow access through compassionate use.  They have no obligation to do so. The FDA cannot compel them to do so.  If the company agrees to make their drug available for compassionate use, the FDA approval in reasonable circumstances is fairly routine.

There are several reasons the drug company may not approve compassionate use.  There may be limited drug supply.  They can be concerned about compassionate use taking patients away from clinical trials. The drugs may be used in less-controlled settings on sicker patients, setting them up for more side effects be­ing reported.  The company does not gain much useful information.  The data from compassionate use is not included when going for FDA approval, but any side effects have to be tracked and reported.  So in fact, it is often not in the company’s best interest to allow compassionate use.

We decided to apply for compassionate use of elotuzumab.  It’s fairly far along in clinical testing.  As a mono­clonal antibody, it’s a completely different category of drugs than anything I have been on. Combined with other myeloma drugs, elotuzumab is showing some good, durable responses.  Elotuzumab is likely to be the next multiple myeloma drug approved by the FDA, but that could be a year or two off.

My doctor sent the appropriate paperwork to the maker of elotuzumab, Bristol-Myers Squibb (BMS).  It took over two months to get an answer: “The senior medical group of BMS met to review compassionate use of elotuzumab.  New compassionate use requests will not be considered at this time.”

Denied! Are you kidding me? The thing to understand is that compassionate use is not necessarily about compassion.  These are carefully calculated business decisions being made by the drug companies.

BMS is getting ready to go for FDA approval for elotuzumab and does not need any reports of new side effects.

So now what?  One more last ditch appeal? More chemo? Other drugs through compassionate use? Using genomic testing information?

I am exploring all options and not giving up yet.

───────────────── ♦ ─────────────────

Update (Feb 14, 2014) - After The Beacon published the above column, the Beacon staff contacted Bristol-Myers Squibb to make it aware of the column and to see if it wished to make any statement in regard to it. A BMS representative responded, saying that the company does not comment on individual patient cases, but that it did have the following statement:

Bristol-Myers Squibb is committed to developing medicines in areas of high unmet medical need. In many cases, our medicines are being studied as potential treatments for patients with limited to no viable treatment options. It is exactly with these patients in mind that, through regulatory approval, we work to ensure broad access to our medicines as quickly as possible, while also remaining mindful of protecting patient safety.

In the long term, the best way to ensure the broadest access for patients is to successfully register a medicine with health authorities through the conduct of well-controlled clinical trials.

In certain cases, Bristol-Myers Squibb has offered investigational medicines in late stage development to healthcare providers for the treatment of patients outside of clinical trials, after evaluating the degree of unmet medical need, the availability of other treatment options, and the extent of available safety and efficacy data on the compound at the appropriate dose.

We empathize with patients who have limited treatment options and are committed to establishing the benefit / risk profile of elotuzumab as quickly as possible. Our Phase 3 program for elotuzumab is on­going and we are closely collaborating with health authorities.

Arnold Goodman is a multiple myeloma patient and columnist at The Myeloma Beacon. You can view a list of his columns here.

If you are interested in writing a regular column to be published by The Myeloma Beacon, please contact the Beacon team at .

Photo of Dr. Arnold Goodman, monthly columnist at The Myeloma Beacon.
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32 Comments »

  • Nancy Shamanna said:

    Hi Arnie, I am sorry to hear of your problems with getting some elotuzumab, and also with your problems in general with your health. I would definitely appeal the decision of the drug company involved, and send them along a copy of your column! I hope they will see the value in treating you with the drug.

    Otherwise, maybe there are some other 'ab' type myeloma drugs that you could apply for. Best wishes.

  • Eric Hofacket said:

    Arnie,
    You and a few other of the writers for the Beacon are in a position I hope I never get into. Running out of readily available treatment options with the promise that new ones may soon be available if you can just hang on for a little bit longer. Wishing you success,
    Eric

  • Rhonda said:

    Dr.Goodman,

    I was previously a patient of yours and was very sad to hear of your diagnosis. A few years after you were diagnosed with MM, I was diagnosed with MGUS. I have followed your story (and many others on this website) with prayer for each of you. I was disenheartened when I was diagnosed with MGUS and told there was no treatment needed for this MGUS. I understand it is a precancerous condition, but when better to treat it? My Oncologist didn't really have an explanation. So, I went searching for help. I found it in the person of Dr. Elena Morreale.

    I know as a conventional doctor you probably are not interested in what I have to say. But please read this and consider it. My brother-in-law (who lives in VA) was dignosed with mesothelioma about 7 years ago. Told he had 6 months to live after they opened him up and closed him without removing anything. He researched. He found Dr. Morreale. He is still alive and is cancer free of an uncurable cancer. There are many other stories I could tell you. But as for my own, the protein bands that indicate MGUS in my blood cells are gone. They were there for 2 years. I've been seeing her for 18 months. She works with all natural supplements. She had an ovarian cancer patient who was wife to a Mayo Clinic doctor. She had been given 1 year at most. Two years later she's cancer free and evidently Mayo Clinic is looking into the procedures used by Dr. Morreale. She is in Tampa. It couldn't hurt anything to give her a call or go for a consultation. You could do this in conjunction with your current treatment. I just know what she's done for me. In so many ways. I was never a believer in "alternative medicine" until I needed help. I sort of doubted even though a family member was helped by her. He made many trips here from VA and she has patients from all over the country. But she's made a believer out of me with no quackery. These are supplements anyone can buy. The dosage is the tricky part. It is often changed with every visit.

    I wish you the best. You are in my prayers. I always considered you my favorite doctor and miss your advice.

  • karenh said:

    Arnie,

    I think that I emailed you earlier when you were deciding about having the allogeneic transplant as I had had one as well. I was initially diagnosed with aggressive extramedullary disease.

    I am doing well right now but know that for me and all of us with this disease, this can change at any time. Thanks very much for sharing the information about compassionate use policies. I'm sure that this is something most of us know little about. Would it be helpful to lobby the FDA to eliminate the requirement that side effects from drugs used for compassionate use be reported? Or perhaps one doesn't lobby the FDA? I don't know whether the IMF collectively could do this or whether it's even a good idea to change the reporting regulation, but it doesn't seem to be working in a good way now.

    At any rate, I hope the next news on the horizon for you and your family is good. Karen

  • LibbyC said:

    Arnie,

    I am sorry to hear of this latest development. "Never give up, never surrender" - a line from Galaxy Quest, a spoof of Star Trek.

    I am sure you have thought of the following but I just want to help.

    If you are going to appeal BMSs decision is there anything that we (the Myeloma Beacon community) can do? Social media can be a powerful tool & there are many of us with many friends & relatives - some of us are young enough to be on FB :). I'm sure your old patients would be willing to help. I'm sure that some amongst us work or used to work in advertising. I think we could come up with a fantastic sell of why the company should give you, a doctor who has devoted himself to helping others (with cancer) etc., the drug based on compassionate use. Let us know if thats an option you want to pursue.

    Do you know of anyone in the pharmaceutical industry (specifically cancer drugs)that knows someone who knows someone in BMS? Unfortunately I can't help you there as the people I know in the cancer drug industry are in Australia. It would be a help even if it is the rep that comes around to the doctors offices trying to get you to buy their drugs. They would know someone who would know someone ...

    Never give up, never surrender.

    All the best,
    Libby

  • Terri J said:

    I am basically new to the myeloma world with my daughter who was diagnosed in Jan. 2012 She is in remission after a transplant in August 2012. There is a doctor doing great things with blood cancers at the University of Pennsylvania named Dr. June. Yes they may be last resort things but they seem to have worked for a number of people.

  • Mary Degenkolb said:

    Arnie,

    My best wishes and prayers go out to you. I have learned so much from your articles in regards to different types of treatments and novel drugs. Now I have learned about another way to get trial medications. I just hate that you have to go through all these gyrations to deal with your myeloma.

    Maybe, with Tom Brokaw being known to have multiple myeloma, we will finally get the news coverage we need for research and drug development. I am currently in a holding pattern, with one doctor saying I'm in relapse (the BMT clinic doctor that follows me since my stem cell transplant with my own cells in 2011), and my regular hemotologist oncologist I see each month saying "what?". So I have geared myself up for a new fight!

    I will not recommend any treatments, as every myeloma is different. I just wish you the best and would tell you that Georgia Regents University, that used to be the Georgia College of Medicine, has an awesome clinic in Augusta! There is a new doctor that is "the man" when it comes to myeloma. He is French, but what I have been told, he is the doctor you want. Please email me if you want the phone number for the BMT, myeloma clinic in Augusta, Ga. And I will give you all I have to call them if you want!

  • Gary Faust said:

    Arnie,

    Thanks for sharing your difficult journey with all the Beacon readers and myself, a fellow MM patient. I am currently in remission from a fairly aggressive type of MM, which responded well to Revlimid, Velcade, and Decadron. My heart goes out to you and your fight against this tough cancer. I have always read your columns with great interest because you have a doctor's understanding of the medications and treatments available to us.

    I just wanted to say that you are an inspiration and that I hope you have success in your continued fight. Keep your head up, keep up the good fight, and know that there are so many of us pulling for you to return to remission and good health.

    God bless you and stay strong.

  • Bev Baccelli said:

    Arnie,

    I look forward to your column every month. I was diagnosed in 2008 at stage 59, had a auto SCT and was in remission for 4 yrs. After relapse a year ago I started on Revlimid/Dex maintenance but that isn't working well now. Next stop: Pomalyst in April. Looks like I'm just behind you on this MM road. I've been talking with my oncologist about genetic testing (reread your 2011 column on this topic first) and did not get an enthusiastic response. Have you considered pursuing this course? I don't know anyone who has. I'm concerned that some of the standard and even new treatments may do more harm than good.

    Having been a kayaker, cyclist, tennis player and skier, it's been hard, as you know, to adjust to this MM reality.Last ear I was stuck in cold, snowy Massachusetts all winter due to possible side effects of the Revlimid. This year I told my oncologist I was going to Florida, even if I went on a stretcher. Fortunately, I'm doing well enough to drive our camper van down South for the month of March. I'll be thinking of you when I'm kayaking off Honeymoon State Park and Fort DeSoto!

    Thanks for your insightful and informative columns. Hang in there!

  • Scott H said:

    Hi Arnie,
    I so hate to hear of this crossroad you find yourself at. Buddy, you are a trailblazer as fa as I'm concerned, not to mention an inspiration. I am wishing you much success with your future treatment decisions. Hang in there!

  • Michael said:

    Dr.Goodman,

    Did you check a possibility to use the following drugs: Afinitor (Everolimus); Romidepsin (Istodax); Vidaza; Arava (leflunomide); Ritonavir with Metformin; Arsenic trioxide; bendamustine (Treanda)? Maybe some of them will help? I can provide you with additional information if you heed.

    All the best.

    Michael

  • Multibilly said:

    Hi Arnie,

    This just breaks my heart to hear that you were turned down. It seems like there really are quite a few other drugs (literally dozens) in various states of trial for R/R patients for which you can apply for compassionate use. They span everything from MABs to IMIDs and many new mechanisms. I trust you already searched the drugs in trial for R/R patients at:

    https://myeloma.org/ResearchMatrix.action?tabId=26&menuId=207&queryPageId=14

  • Stuart said:

    I think what Bristol-Myers has done in your situation, Arnie, is unconscionable. The decision not to approve your application makes a mockery of anything the company says about caring about myeloma patients. What I find even worse is that the company was so callous that it couldn't find the resources internally to respond to your application more promptly. Two months? This is the same company that has spent literally hundreds of millions of dollars plastering the airwaves and Internet with advertisements for its antidepressant Abilify.

    Maybe that says something about the company's priorities.

    My hope is that your column will be a wake up call to BMS and to other companies developing MM drugs. I also hope BMS reconsiders its decision, and that other companies won't make similar decisions in the future.

    If BMS doesn't change its decision and its policies, maybe patients and physicians, and perhaps even the FDA, need to keep that in mind for the future.

  • Wife101 said:

    My husband was diagnosed in 2009. We live in Canada and at that time Health Canada had not approved Revlimid, which was our doctors drug of choice. She became very creative and basically jumped through the hoops that Celgene held out for us. She termed us as reverse snowbirds. Is this drug approved anywhere else where you can claim partial residency? Just a suggestion, it worked for us. Good luck and our best wishes.

  • Gary Petersen said:

    Sounds to me like Bristol-Myers Squibb is not very compassionate. Bunch of &^%%&$# heads. Maybe the Dutch with Daratumumab will be a little more compassionate. The results of the RdDar have been excellent in heavily pretreated patients, and in vitro RVdDar is 50% more effective.

  • Michael Lapides said:

    Arnie,

    I'm feeling pretty good right now. Back to lap swimming which seems to be the most important part of my therapy plus Kyprolis, Dex and Pomalyst which are working for me right now. But I'm scared as hell of the day every thing turns back to shit which it has for you and will for me.

    Mel Ott, Geraldine Ferraro and now Tom Brokaw. All that's done is help people not confuse MM with Melanoma and I'm not sure that's even happened. So I wouldn't hold out any hope that Brokaw's situation is going to make any difference unless he decides MM has something to do with WWII.

    You've pounded yourself with every available agent. Now what? I wish I knew. There are many good suggestions in this comment string. I've got nothing meaningful to add except to say that all your columns have been inspiring but this one was a true gift and I thank you for that.

  • Igor said:

    Arrie.

    May be you should try few shots of vaccine against pneumonia. Few studies claim that vaccination can improve outcome of MM. May be it can wake up your new immune system. Anyway it can not harm too much and at least can protect you from pneumonia that common in MM patients.

    Bellow link to small study that show Prevnar (pneumonia vaccine) improve response to Revlimid.

    http://www.myelomabeacon.com/resources/mtgs/ash2013/abs/1980/

    Stay strong!

  • Mike F. said:

    Thanks for keeping your column going under trying circumstances, Arnie. That is of great value to all of us who are living in the myeloma world. Please do hang in there and keep pushing. Many of us here are thinking of you.

    Mike

  • Thomas said:

    Dear Dr. Goodman, in critical stages of myeloma - as you describe it here - bureaucracy works against us patients. Time is a crucial factor and we need solutions fast(er). Perhaps the new CD38-antibodies (MOR202/daratumumab) could resensitize your myeloma to Kyprolis/Pomalyst. But again - the problem is, you need it outside a study. What I learned from your text is that communication (2 months) needs too much time. Just an idea: Perhaps we could have here, or at the IMF/MMRF, a kind of red alert-group, where experts support patients who need help and newer agents immediately. Kind of a new agent pathway. But I'm sure, Dr. Goodmann, you and your doctors will find a way. My thoughts are with you.
    Thomas

  • Arnold Goodman (author) said:

    Thanks everyone for your thoughts, comments and well wishes. I have to be frank though. I fear I may have missed my mark with the column. My goal was to update and to inform people about what I had learned about the compassionate use process and how difficult it can be. I didn't really want to make it about me.

    It is not easy to get unapproved drugs outside of a clinical trial, and clinical trials have some significant limitations. There is not really a matter of somebody that knows somebody that that can get it, its much more structured than that. That was the point I was trying to make. As a said in the article, whenever I write something like this I get lots of comments with suggestions. I do appreciate it, but everyone is different, and I have investigated almost everything and most are just not applicable to my situation or way too early in development.

    I do think there has to be a better way to access some of theses drug , such as Thomas's suggestion.

    For the time being I'm still working on elotuzumab, and also other monoclonals like daratumumab in combo with other drugs do seem like good options. Some type of maintenance chemo doesn't seem crazy at this point either.

  • Eve said:

    Hi

    I have been following your post for some time, just wished to say you have been very informative and this has helped me looking after my husband.

    We live in England and my husband has had myeloma for 3 years. He has had CDT, CDV then SCT then CDR. Currently told no more treatment available as damage to platelets?

    After second opinion he is being treated with CDV with platelets support.

    I just want to tell you Arnie how much you have helped people like me. We know in England we do not have a chance for many of the drugs offered to you, but it does lead the way for NICE and Europe trying these drugs for people who cannot get on trials because of the criteria.

    So give yourself a pat on the back Arnie.

  • Jeffrey Patterson said:

    Youv’e probably tried mate but here’s my “2 bobs worth”.
    How about some of the new antibody therapies like daratumumab and sar650984 there are Phase II trials I think, for refractory clients. There is another antibody (elutomumab I think)that’s been paired with a chemo –doxil- I think, I thought it was showing promise++.
    How about [Chk1 inhibitors are currently used primarily in conjunction with conventional DNA-damaging chemotherapeutic agents," says the study's lead investigator Steven Grant, M.D., associate director for translational research, Shirley Carter and Sture Gordon Olsson Chair in Oncology Research and professor of internal medicine at VCU Massey Cancer Center. "By combining Chk1 inhibitors with another targeted agent, such as Src inhibitors, we were able to induce cell death in multiple myeloma cells while sparing healthy, normal cells."]
    There is MDX 1097 here in Australia that is being trialled with Lenalidamide but limited support so far.
    How about these activated T cells that are expanded and sensitised to your myeloma before re-infusion, or am I getting into the realm of science fiction.
    I wish you all the best my friend. I suspect the academic, dispassionate way you can discuss our predicament and diminishing treatment options belies the emotional journey we share. From one MM to another thankyou, God Bless you on the journey and good luck.

  • stann said:

    Hi Arnie,

    I plagiarized this from Gary (above):

    "Thanks for sharing your difficult journey with all the Beacon readers and myself, a fellow MM patient. My heart goes out to you and your fight against this tough cancer. I have always read your columns with great interest because you have a doctor’s understanding of the medications and treatments available to us.

    "I just wanted to say that you are an inspiration and that I hope you have success in your continued fight. Keep your head up, keep up the good fight, and know that there are so many of us pulling for you to return to remission and good health"

    I'm sure when you sat down to write this column, your energy level was low and it was a real project to write it. Thanks again for sharing.

  • Myeloma Beacon Staff said:

    Thank you, everyone, for the excellent discussion on this article.

    The Beacon has received a statement from Bristol-Myers Squibb in regard to their compassionate use program, and we have included it above at the end of the column.

  • Pat Killingsworth said:

    As difficult as your situation is, Arnie, I hope you can take comfort in knowing that your contribution to the multiple myeloma community is priceless! I can honestly say that I have never read an article or column that contained more information about so many often misunderstood topics. Following your myeloma journey has helped educate a generation of patients and caregivers. Arnie, you have been dealt a tough hand. But what impresses me has been your single minded determination to survive--and help us, too. Thank you!

  • chen5631867 said:

    I am sorry to hear your suffering and difficulties that your multiple myeloma had recurred again with aggressive extramedullary disease. My family membership has treated this disorder on stage VI by Velcade, Revlimid, and dexamethasone since March 2011 at Stanford Hospital after having two stents in her bile duct. Also had acupuncture and Chinese herb tea at private clinic around one year and half.

    Then her two tumors, one 15 cm on pelvic and one 9 cm on pancreas without being able to have a surgical process because of been too big after three times of biopsy. There are very successful treatments without a BMT and any transfusion.

    Now, she only do need maintenance chemotherapies by two Velcades a month as a cycle without find tumors in her body under CT screens in Stanford, UCSF, and VGH in Taiwan, and feel very health after one or two hours of walking and shopping.

    It might be only one case that the patient still is alive on 50 cases of English speaking countries under my knowledge

  • Mark Gershenson said:

    Arnie, your well-written column illustrates that we have too much government, and that Big Pharma usually shows very little compassion for anything except its bottom line. I'm not going to offer you any treatment suggestions because my knowledge of multiple myeloma is limited to what I have read in your column (although I think that Rhonda's suggestion that you see Dr. Morreale for a consult makes good sense given that she is local). Instead, I offer you encouragement. As Bruce Springsteen wrote, "No retreat, baby, no surrender." Your are in my prayers.

  • Chrystin said:

    My husband lost his father to multiple myeloma. I am going to create a petition for your cause on change.org. If you already have one PLEASE let me know so myself and my husband can sign it and send it around. Compassionate use is just that, "compassionate". It aggravates both of us to hear of your situation and we will do anything we can to help you.

    Thank you,
    Chrystin

  • Arnold Goodman (author) said:

    Chrystin,

    Thanks for your support, but I wanted to let you know that, since I wrote my article, Bristol-Myers has reconsidered its decision and has re-opened its compassionate use program. I will write more about it in my next column, but things did work out in the end. So, while I appreciate the support, I would ask that you do not initiate any type of petition campaign.

    Thanks,
    Arnie

  • Yaron said:

    Arnie,

    Thanks a lot for sharing your experience. My beloved brother is in a very similar devastating situation (post allo, refractory to: Velcade, Revlimid and carfilzomib). I would really appreciate following up with you by email to learn about potential alternatives that you might have found during your research. Please let me know how I might contact you.

    I hope you will find a treatment option soon.

    Warm regards,
    Yaron

  • Arnold Goodman (author) said:

    Yaron, that is a tough spot to be in and I know it well. The most successful thing for me so far has been the high dose chemo VTD-PACE. DCEP might work also, but these are unfortunately only temporary solutions. Beyond that, I am still searching for the answer. For now I will be trying the monoclonal antibody elotuzumab through compassionate use in combination with the other myeloma drugs. The other monoclonal antibodies in development might also be good, but I they do not seem to be available for compassionate use. Genetic testing for a targetable mutation is also an option through Foundation Medical. Happy to talk further. If you contact the Beacon Staff they can provide my email.
    Arnie

  • Yaron said:

    Dear Arnie,
    Many thanks for your response, I will contact the Beacon staff to recieve your email and will follow up.
    Yaron