FDA approval for crizotinib and a new name: Xalkori

On Friday, August 26th; crizotinib received FDA approval. It is now called Xalkori. Nice little features on both the ABC  (scroll down to find Xalkori) and NBC evening news a couple of nights ago. That’s my oncologist/goddess Dr. Alice Shaw providing commentary, and in the NBC piece, the images of the before and after chest CT scans are my lungs (an online friend recognized them and emailed me!). They do get around (my lungs and Alice).

I should also mention that there was a story about Pfizer’s coup in the Wall Street Journal on Tuesday with a picture of and a few quotes from yours truly. My Dad Ollie, who read the WSJ faithfully, would have been pleased to see me there.

I’ve noticed some criticism on the blogsphere, as Xalkori comes with a hefty monthly price tag ($9600), but Pfizer has taken steps to provide financial aid for those who need it. Also called out has been the fact that only 4-6% (or according to this latest data, almost 10%) of people with NSCLC have a mutation of the ALK gene. However, there are so many cases of lung cancer world wide (according to WHO, 1.4 million deaths yearly from lung cancer), that when you do the math, it is a truly significant number of patients who shall potentially benefit.

So yes, Xalcori is big news for Pfizer as well as those of us with lung cancer and the FDA is to be applauded for streamlining the often ponderous approval process.

And now, on a more personal level; what’s up with me.

On August 19th I took my final dose of crizotinib (Xalkori). I am now ‘washing out’ in preparation for my next party trick (make that a miracle). Yesterday I peed in a cup, had bloodwork, a physical, an EKG, a chest and abdominal CT (with contrast–blech) and a PET scan as well. I was given one of those nifty cards identifying me as residually radioactive for 24 hours (just in case I encountered someone with a geiger counter).

I am scheduled for my lead in dose of LDK378 next Wednesday and that’s when the circus really starts.

In the meantime, I am feeling pretty crappy. I saw Alice (Dr. Shaw) yesterday, and she thinks that quite probably, the crizotinib was still conferring some protection, which is good news if in the future we want to add it to my arsenal again. Now that I’m off treatment, my energy level has really dipped and my shortness of breath is catching up to me. Today I made myself go on a walk, as I’ve been breaking my own rules lately (never stop moving). It was also Peter’s first day at the Academy, and he’s going to require a lot of support as he adjusts to a very rigorous academic schedule, so I’ve got to stay on my toes.

What can I say? It is a stressful time for all of us, but we are doing our best to stay positive and hopeful. Because that’s how it’s got to be.

33 responses to “FDA approval for crizotinib and a new name: Xalkori

  1. Linnea – I have been holding you in my thoughts a lot. I say, be the poster girl for this next drug too – you already know how to handle the pressure and the publicity!
    I’ve been breaking my rules lately as well – maybe it’s just that time of year. Be good and do great.

    • Stephanie, I am a rule breaker in general (my naughty nature) but some rules are meant to be followed. I will get my sorry ass out there again today. And hey, you’ve been in my thoughts too. Don’t we have a date for tea or coffee or something soon? When, where, how?

      Linnea

  2. All good Linnea…pace yourself and congrats to Pete. Your Sherpa…..

    • Hey my little sherpa (god I hope that’s PC), miss you. Not sure if I’ll make our last class (cancer keeps getting in the way of my social engagements) but if I can’t come, maybe we’ll have appts. on the same day and or you can just come to Yawkey for a visit. I think they’re giving me an apartment on the 8th floor…(great views).

      Linnea

  3. I love you Linnea “because that’s how it’s got to be.”

  4. I’m rooting for you too! I’ll be thinking of you next Wednesday. I have good vibes about you finding your second miracle. Xalkori will be just chapter 1 in your book with lots more amazing stories to be told.
    xoxo Evie
    P.S. I recognized your lungs too!

    • Evie, I’m glad you keep checking in. Makes me feel good knowing you’re out there. One of these days I’m come to the city of brotherly love. Look for me! And you stay well.

      me and my lungs, Linnea

  5. I really appreciate you and all the others in the trials.Had my biopsy tuesday,for Alk+,Egfr and to make sure my mets are still the same lung cancer.They Are.Awaiting the other two results.Thinking of you.

  6. I’ve been reading your blog for some time now, but have never commented. I am in the Crizotnib trial and go to Sloan-Kettering in Manhattan. The oncologists there have told me I will probably become resisitent to the Crizotinb and have to go to something else like LDK 378. No problem for me. Sure beats chemo. My quality of life is so much better now. Tumors have shown some shrinkage but still there. Some of these bloggers are complaining about the price. I say that it seems cheap compared to the $75,000 price of each chemo cocktail infusion that I had. Best of luck with the new trial.

    • Hey Larry, thanks for introducing yourself and I hope Crizotinib (Xalkori) does the trick for you for some time to come. Nothing about cancer treatment is cheap (my procrit shots the day after chemo were $1500 each), and I’m rather disappointed by all the naysayers. Hard not to take it all personally when they are talking about something that is saving our lives and doing it ever so much more gently than traditional chemo (or surgery–that’s a tough one, and not cheap). Best of luck to you as well.

      Linnea

  7. From one survivor to another.
    Always thinking about you.
    Cheryl

  8. Hi.

    I am a patient at Sloan Kettering. Today I was told I receved a lot of chemo. I took that as my choices were limited. Any advice would be great

    • Joe Billie, I would ask for some clarification as far as what they mean. At one time I believe there was a thought that after three failed treatments, there were limited options, but lots of us have been on more than three (and counting). Have you been tested for mutations?
      Keep asking questions and pushing hard if you desire more treatment (and never be afraid to ask for a second opinion). Best of luck,

      Linnea

  9. Hi Linnea,
    As a fellow Crizotinib trial mate from CT (Phase II since 6/10) who has followed your blog for sometime and admired your cat scan before and after films, I, too, recognized those lungs on the news clip the other night. So impressive! I wish you all the best with LDK378 and hope your feeling better real soon. Thank you for sharing your experiences. It’s been so helpful!
    Sharon

    • Sharon, thanks for the good wishes and support and isn’t it funny that you would recognize my lungs as well. Let’s hope LDK kicks butt!

      Best, Linnea

  10. Linnea just read your last post and was touched with your last sentence. I want to share with you part of a letter Jack Layton (Canadian politician) wrote to Canadians upon his death recently………

    To other Canadians who are on journeys to defeat cancer and to live their lives, I say this: please don’t be discouraged that my own journey hasn’t gone as well as I had hoped. You must not lose your own hope. Treatments and therapies have never been better in the face of this disease. You have every reason to be optimistic, determined, and focused on the future. My only other advice is to cherish every moment with those you love at every stage of your journey, as I have done this summer.

    I am keeping all fingers and toes crossed that your new treatment is effective. My best wishes to you, David and Peter as you start this new journey.

    • Beryl, so good to hear from you. Gil talked of Jack Layton–it sounds as if he was a wise generous and courageous man (not always adjectives I would use to describe most politicians).

      I have my down days (unavoidable) but I never stay there long. Tomorrow is the day I start the trial, and I will go in fighting.

      Love to you,
      Linnea

  11. Hi Linnea- I had been looking for an update. Sorry you are feeling lousy during the “washout” period (apt name, that) and hoping that you will feel better after your first dose of the new agent. I remember my husband’s dramatic response to Tarceva, literally within a few days of commencing the regimen. Tried to tie him down to prevent him from shoveling the driveway a month later during “Snowpocalypse 2010.” (didn’t work). Good luck. You have a big fan in Virginia who is pulling for you.
    Joan

    • Joan, since I’ve procrastinated, I have two comments to respond to from you 🙂 Thanks for the support–and I can readily relate to your husband and the snow shovel. David bought me some new garden snippers the other day, and twice I went out to the woods clearing small trees until I was literally breathless. Imagine what I could do with some more energy!

      Linnea

  12. Hey beautiful friend,
    I hope the weekend is treating you with kindness and rest, making you feel a bit stronger. In Stockholm, it’s Sunday evening and I’m pleased the 7th is coming closer. We’re having a count-down for you – it’s time for a new mystical acronym to kick in.
    Strong hugs for you, once again,
    Anja

    • Anya, I have been enjoying picturing you wheeling me around on your bike. If you think of a good mystical acronym (or spell, or chant, or whatever!) please pass it along. Thinking of you and so happy you are well–I spoke to August yesterday and he asked about you and was happy to hear that things are stable. Let’s keep it that way!

      Love, Linnea

  13. Richelle Johnson

    Hi Linnea, I have been following your blog since my mum was dx in May 09. I believe you have one life to live and you fight like hell to live it. My mum is on trial in Australia for crizotinib. I thank you for being the “pioneer” in this drug. You have given so many others hope and courage.
    The part about the cost of the drug…..i bet the people who say the negative stuff…if it was them or their loved one they would be thankful that there was something available to treat them. I say if something costs a lot of money but only saves one person than it is worthwhile. money isn’t everything. Best of luck on your next treratment. Richelle xx

    • Richelle, thanks for the howdy. I all for fighting like hell (even if I have moments when battle fatigue settles in for a bit) and I’m ready to go to war tomorrow. Best to you and yours…Linnea

  14. This is the first time I have read your Inspire piece that lead me to this wonderful blog. My wife has KRAS mutation and is starting a trial with AZD6244 at NIH this week. Do you know of others on the same drug? Also, please educate us on any other drugs for this mutation.
    All the best to you
    DK3

    • DK, good luck to your wife on her trial. I really don’t know a lot about the KRAS mutation, but if you google you may find blogs related to it. One of my possible options is an HSP 90 inhibitor; perhaps it is effective for those with KRAS mutations as well. The best to you as well,

      Linnea

  15. Think of you often and was drawn to L&B this morning because I seemed to remember that something was coming up. Another new “adventure,” it seems. I’ll start saying lots of obstacle-clearing prayers for you, Linnea! xo Mary Wasserman

    • Ah, Miss Mary. It has been to long; some night we need to schedule a dinner with you and Bill. I’ve been getting a jones for Cranes as well. Perhaps we could drive south and meet at a restaurant for a meal and a chat and a walk on the beach. And I say yes to those prayers!

      Love, Linnea (I just had toast with some of Bill’s jam–an older jar–the other day)

  16. Hi Linnea,
    sorry for my English, I’m an Italian guy, 35 years old and I live in Rome. In November 2010 I knew that I had a NSCLC and i started the Chemiotherapy but the results weren’t good. My oncologist told me to try to see if i had the ALK mutation and i found it. I started to take Crizotinib the 26 may 2011 with positive results untill 23 february 2012 when illness was getting worse. Now my oncologist proposed me to enter in the LDK378 trial. I’m really confuse what to do because there are so few informations about this drug. I hope you are fine and that this drug is working, i would like to know your suggestion, your experience could be very important me. thank you so much, Stefano.

    • Stefano, I am sorry you have been stricken with this disease at such an early age. It is good that you know you have an ALK mutation and also good that you got almost a year out of crizotinib–fairly typical. Minus the little break I just had for elevated liver enzymes, I have been on LDK 378 for 6 months now. My response rate has gone from 20% initially to 62.4% now. I was on a higher dose when I had the elevated liver enzymes (500 mg) and have rechallenged at 400 mg–the original dose I entered trial on. At that dose, I noticed few side effects. There are those in trial at 700 mg who are managing, but it just appears to have been too much for my body to handle (although I would be open to going up in dose again in the future if necessary). I know of a handful of people on this trial, but they are all doing well. I would encourage you to consider enrolling in the trial–we are at a time in medicine when we need to take each new step as it is offered to us, and for those of us with ALK mutations, this is a viable next step. Best of luck, and feel free to contact me anytime with questions or just to talk about your situation. I wish you the best of luck.

      Linnea

  17. My husband has been on Xalkori for 2 weeks and he feels so much better. I have been reading this blog for 2 weeks hoping someone will write more so that I know what to expect. I am swimming in the dark. Please write more and tell me how you are doing.

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