A quick post today, because I'm visiting family and I like playing with my nieces and nephews more than I like writing about cancer.
A few days ago, the European Commission gave approval for the CAR-T treatment Lisocabtagene maraleucel (also known as Liso-cel, also known as Breyanzi) for treatment of Relapsed or Refractory Follicular Lymphoma after two previous treatments.
This is, of course, excellent news.
About six weeks ago, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval, so now it is official. Liso-cel should be avaioable for patients who meet these criteria in the European Union, as well as Iceland, Norway and Liechtenstein.
Liso-cel has already been approved in the EU for a few types of lymphoma, including R/R Diffuse Large B Cell Lymphoma , high grade B Cell Lymphoma, and Grade 3B Follicular Lymphoma. The FDA gave the same approval for Liso-cel last year in the U.S.
It will be very interesting to see how quickly CAR-T is approved for first-line treatment for FL. As far as I know, there has not been such an approval yet, anywhere. There are certainly clinical trials in place for this group of patients, with some good initial results. It will be interesting to see how popular CAR-T becomes once that is in place.
There are some fascinating politics and economics when it comes to getting a treatment approved. Most companies take the strategy of trying to get third-line approval with their initial application. It is the most likely to get approved, because there is the greatest need for new treatments among patients who have already had a couple that didn't work. Once that approval has been given, and some money is coming in, it's easier to work on trials to get first-line approval. (If you want to read a fascinating book about the development and approval process for Ibrutinib, check out For Blood and Money: Billionaires, Biotech, and the Quest for a Blockbuster Drug by Nathan Vardi. A great behind-the-scenes look at the process.)
That's all for now. I need to go see what my niece learned in her Scottish Country Dance class.
4 comments:
Wow this is great news for us in Europe! Does this mean the health insurance will cover it? Or is this a first step, and now every country has to negotiate with insurance companies?
Fer, in the Netherlands it will be covered by the health insurance. I do not know if they will cover it in other european countries.
Ron(the Netherlands)
Well I luv in the Netherlands so that makes me happy.
https://www.zorginstituutnederland.nl/publicaties/adviezen/2024/12/16/pakketadvies-sluisgeneesmiddel-lisocabtagene-maraleucel-breyanzi-voor-de-behandeling-van-lymfeklierkanker#:~:text=De%20minister%20van%20Volksgezondheid%2C%20Welzijn%20en%20Sport%20(VWS)%20heeft,het%20vergoedingsbesluit%20in%20de%20Staatscourant.
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