Lemtrada (Campath) in the news

[Marco]

The U.S. Food and Drug Administration reviewers have "significant concerns" regarding the safety and efficacy of Sanofi's multiple sclerosis drug Lemtrada (alemtuzumab).

In a briefing document prepared for next week's advisory board meeting to discuss the drug's approval, one FDA reviewer reported that he the drug has "serious and potentially fatal safety issues." Specifically, in clinical trials, patients have developed a variety of autoimmune diseases as well as thyroid cancer and melanoma.

http://www.businessweek.com/news/201...fda-staff-says

[MSer102]

I think it's apparent that Lemtrada won't be a first line treatment because of the significant risks. I'm wondering though how it can be prevented from being used that way.

Before Biogen figured out how to test reasonably reliably for the JC virus and devised a way to gauge risk basked on the titer index, the TOUCH program was supposed to be a foolproof way of ensuring that Tysabri - because of the risk of fatal PML -would be used only after it was proved that Copaxone and one of the interferons couldn't be used by that patient for some reason.

Yet somehow many doctors were able to get patients on Tysabri as a first line treatment for reasons as simple as the person didn't want to do injections. So the TOUCH program wasn't working as the safety program Biogen promised the FDA it would be.

So how will Lemtrada be controlled? It will have to be a much tougher safety program than TOUCH.

And if Lemtrada gets turned down by the FDA for safety reasons, it might oddly become even easier for patients to get it. Campath has already been approved by the FDA. All the manufacturer would have to do is put it back on the market as a cancer treatment and doctors will be able to prescribe it off label for MS. Great for the people with MS who think they want any treatment at any risk, but tragic for the people who don't really understand what the risks are and end up with other lifelong diseases they can't handle or end up dying from a preventable cancer.

It will be interesting to see what happens, no matter what it is.

[Thinkimjob]

And apparently, the price is going to rise astronomically, if what's happened in the EU is anything to go by, when it's no longer an off-label drug but a designated MS treatment.

Still "cheap" if you've got leukaemia, much, much, much more expensive if you use it for MS.
Different name and everything, so they can pretend it's not the exact same drug.

[MSer102]

Another poster just shared this link to another article about the FDA's upcoming review of Lemtrada.
http://www.medpagetoday.com/Neurolog...09&utm_content

Uh-oh! Submitting invalid data - and hoping nobody would notice - doesn't look good for the manufacturer or Lemtrada's review.

[spacedive]

Sometimes the risks are outdone by the truth. Campath has worked for me, the dark clouds have cleared from my head and body to see this awesome world we live in. I don't think it's a cure, but it's right next to it. If things are not perfect in their data so what, Campath has helped more people than just me, in fact I'm meeting 5+ people next week who all say the same thing. Campath works!

[its2much]

One of our members is going to DC

this is posted on the medication board:

Campath
Genzyme is flying me out to Washington DC next week to testify to the FDA committee for Campath.

I'm doing this for myself and any other people that are struggling with MS.


Please pray for my safe trip.

Thank you everyone.

-Harold

I wish well and you a safe trip

[Thinkimjob]

That's a relief for me to hear, spacedive, because I'm booked in for Campath in June next year.
I really hope it does what it says on the box. All the best.

[KatieAgain]

Good Luck in Washington next week Harold! It is nice to hear Campath worked for you.

I think all the MS Drugs should carry warning labels of the potential risks, patients be informed of the risks and allow the patient to make an informed decision, based on their current life situation. Have the patient sign a letter acknowledging the risks. Although I am not a huge advocate of Drug Companies in general, I also do not support the FDA. Which is the lesser of two evils? Who knows?

Here in Katieville, I am becoming more tolerant of risk as my disease progresses, and it should be my choice as to what is and what is not right for my body.

JMHO.

[pennstater]

I totally agree with Katie. The focus should be on making sure the patient understands risks, if their risks are elevated due to their medical condition(s) and family history, and that the patient is in the right frame of mind to make the decision.

Of course that is if the risks are low and majority of patients won't experience the side effects. I can understand if risk % are too high for a drug that it is more complex and many more factors come into play.

[MSer102]

I think all the MS Drugs should carry warning labels of the potential risks, patients be informed of the risks and allow the patient to make an informed decision, based on their current life situation.

Acftually, that already happens. All brand name medicines come with a copy of the prescribing information that does contain the warning and side effect information. It's just that nobody reads it and they rely on their doctor to tell them everything. And since people forget half of what they hear during a doctors visit anyway they often miss that too.

It sounds like the problem with the Lemtrada studies is that the invalid data used to come up with the effectiveness rates make the effectiveness look better that it really is and the risks look lower than they really are. How can anyone make a truly informed decision about taking a medicine if they're making it based on false information?

[Marco]

I am generally not a fan of the United States, Food & Drug Administration (FDA), but it looks like the drug company (Genzyme-Sanofi) seriously let our community down. Campath had the potential to be one of the most cost-effective treatments for Multiple Sclerosis (MS) patients. It is believed that Genzyme wanted to greatly increase the price of Lemtrada when entering the MS market changing significantly reducing the cost-benefit. A few months later and it's now questionable whether the drug will ever make it to market.

I know a number of MS patients that have use Campath in the past and were looking forward to it being approved. The MS community was once considered "under served," but with the recent approvals of Gilenya, Aubaio and Tecfidera that is a harder case to make. Genzyme needed a much stronger and bullet-proof efficacy case considering the significant safety concerns. Unfortunately, anecdotal information cannot overcome Genzyme's questionable data and poorly controlled drug trials.

This is how Dr. John Marler, FDA reviewer, put it, ""In summary, the two pivotal studies rendered more questions than answers. No sound statistical analysis can solve the problems from inadequately designed and poorly executed studies." Dr. Marler further suggested new studies would need to be performed before efficacy numbers could be trusted.

So the FDA fundamentally questioned the provided efficacy numbers and whether the drug would benefit RRMS patients at all. The FDA questioned whether Campath's benefits were "validly established" So while the data did not sufficiently document benefit they did show serious and potentially fatal safety issues. The primary safety concerns were a handful of thyroid cancers and a nearly 20% rate of treatment-emergent nonmalignant thyroid disorders. Other disorders like hypothyroidism, thrombocytopenia, hemolytic anemia, melanoma, serious infusion reactions were also noted.

A year ago, I was hopeful about the number of new drugs awaiting approval. Aubagio and Tecfidera made it, but I am
hopeful the FDA will reject the approval of Lemtrada. I just feel for the drug trial patients that contract cancer or other serious illnesses in trials the FDA may now deem as worthless.

[KatieAgain]

I am generally not a fan of the United States, Food & Drug Administration (FDA), but it looks like the drug company (Genzyme-Sanofi) seriously let our community down. Campath had the potential to be one of the most cost-effective treatments for Multiple Sclerosis (MS) patients. It is believed that Genzyme wanted to greatly increase the price of Lemtrada when entering the MS market changing significantly reducing the cost-benefit. A few months later and it's now questionable whether the drug will ever make it to market.

A year ago, I was hopeful about the number of new drugs awaiting approval. Aubagio and Tecfidera made it, but I am
hopeful the FDA will reject the approval of Lemtrada. I just feel for the drug trial patients that contract cancer or other serious illnesses in trials the FDA may now deem as worthless.

There is absolutely no doubt that Genzyme let down the Community by pulling the drug, trying to re-market it and then boost the price to increase their profits. There is no hiding this.

There is absolutely no doubt they did not follow appropriate protocols with their trials and research. There is no hiding this.

My beef, and this is with all MS drugs and cancer drugs and the like too, is that for many, Lemtrada/Campath was their last hope. This should not be a first line drug. Some people are at a point where nothing else is working. And for those select group of individuals, I believe they should be offered the opportunity to take the drug after being fully informed of the potential and possible side effects, to include the life threatening ones.

I think it should be an individual's choice. We allow people to undergo Surgery with little chance of survival...after they sign 40 pages of forms. Everyone has a very different outlook and definition of what is an acceptable quality of life. Only that person can determine what is acceptable and not acceptable for them. No one at the FDA walks in our shoes, pays our bills, or takes care of our families.

I too do not believe that Campath will be approved. And even though I personally am not going to take the drug (my hope for me is to move to Tecfidera if Tysabri can blast the two C-Spine lesions I developed, if not I am done with MS Treatment), I hope it is approved for those who have this as their last chance. Some do not have the benefit of waiting a few more years for more aggressive therapy to be approved. I would change that opinion if Campath showed zero benefits for MS patients. Because then we would just be milking the MS Community and the Insurance Companies.

Not sure if the drug will be released again as Campath and Neuros use it off-label...not sure that is even possible at this point.

Just my personal opinion. Won't get into a philosophical or moral debate with anyone. And I respect everyone else's opinion, for we all have one. We can all agree to respectfully disagree.

[Pipes123]

I'm not sure I understand the issues with the risk benefit analysis. Bad data about effectiveness is another different question that I don't know anything about.

About thyroid risk, I take thyroid hormone every day. It's cheap and straightforward. Most thyroid issues can be managed easily. Thyroid cancer can be found and monitored with blood tests and iodine scans. It can be thoroughly treated, eliminated, with iodine 131. It's much easier to deal with than other cancer.

I don't think the FDA is respecting the severity of MS as a disease. For me, it's hard to look at the Campath risks and see how they are worse than Tysabri and PML. I know someone with Leukemia who took Campath. He's doing fine.

The side effect of Campath that might scare me away is the blood clotting issue. Thrombocytic purpura is a nasty condition that I wouldn't want to live with. But I don't think it's in the same league as PML.

I'm currently on Gilenya. I'm scared enough of MS to take some risk.