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Thread: Study: Pfizer lung cancer pill may double survival

  1. #1
    Administrator Top User pbj11's Avatar
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    Study: Pfizer lung cancer pill may double survival

    By LINDA A. JOHNSON, AP Business Writer June 5, 2011


    TRENTON, N.J. (AP) A much-anticipated drug for advanced lung cancer from Pfizer Inc. appears to double survival over standard drugs against tumors with a certain genetic mutation, according to research presented Sunday.


    The drug, called crizotinib, would be the first targeted treatment for the roughly 50,000 people who get this cancer each year worldwide. It might eventually produce annual revenue for Pfizer exceeding $2 billion.


    The first overall survival data for patients with advanced non-small cell lung cancer treated with the drug, called crizotinib, showed 74 percent were still alive after a year and 54 percent after two years, researchers announced at a huge cancer specialists conference.


    Median overall survival, a key measure, hasn't been determined because more than half the 82 patients are still alive.


    The early-phase study did not include a direct comparison group. But among similar patients getting standard cancer drugs in other research, 44 percent survived for a year and just 12 percent were alive after two years, said lead researcher Dr. Alice Shaw.


    Crizotinib, part of the new wave of personalized medicine in which drugs are being matched to patients according to genetics, would be the first drug in a new class called ALK inhibitors.


    The twice-a-day pill targets the roughly 4 percent of non-small cell lung cancer patients whose tumors have a genetic rearrangement of an enzyme that stimulates growth and survival of those cancer cells.


    The experimental drug works by turning off that enzyme, with a rapid and dramatic effect that's long-lasting, said Shaw, a thoracic oncologist at Massachusetts General Hospital Cancer Center.


    "This is not a cure for this type of patients. Unfortunately, ... cancer becomes resistant over time," Shaw added, so researchers already are trying to develop new treatments that could push this cancer back into remission.


    In a continuation of that study, also sponsored by Pfizer, researchers found that among 119 patients whose cancer had worsened after three or more prior types of treatment, 88 percent had their tumors shrink at least somewhat over nearly a year follow-up.


    Similarly, in a midstage study of 136 patients who failed at least one previous cancer treatment, 54 percent had their tumors shrink by about a third or more and 83 percent had tumors shrink somewhat. Most patients had mild side effects, but two of the nine patient deaths during that study were considered treatment-related.
    U.S. regulators are expediting their review of crizotinib, indicating its promise. Pfizer expects it to be approved in the U.S. by year's end, because under the "Fast Track designation" the Food and Drug Administration gave the drug last December, Pfizer was able to start submitting batches of data in January, rather than wait until all studies are completed.


    Two larger, late-stage studies comparing crizotinib directly to standard treatments are continuing, one in patients for whom prior drugs didn't work and one in new patients. There are no treatments specifically for patients with this type of lung cancer, although some others are in much earlier stages of testing.


    So the FDA is expected to conditionally approve crizotinib based on results of the earlier studies rather than wait until the latest ones are completed, said Dr. Robert Sweetman, head of medical affairs for Pfizer's cancer unit.


    Analysts also think the drug is likely to get approved.


    "I think crizotinib is one of the most important ... near-term products for Pfizer," said Morningstar analyst Damien Conover. "It gives a really important new therapy to a lot of patients that don't have very many options."


    About 85 percent of lung cancer cases are non-small cell lung cancer. Roughly three-fourths aren't diagnosed until tumors have spread, and only 6 percent of those patients live five years.


    Conover predicts crizotinib will build to peak sales of about $2.5 billion in about a decade. Credit Suisse analyst Catherine Arnold is forecasting it will bring in $600 million a year by 2015.


    Pfizer, based in New York, also was presenting studies on its other experimental cancer drugs at the American Society of Clinical Oncology conference, which began Friday.


    Those include two studies of axitinib for advanced kidney cancer and three of bosutinib for chronic myeloid leukemia, plus studies of two approved Pfizer cancer drugs, Sutent and Torisel, for new uses.
    Husband diagnosed with NSCLC Stage IV in 3/2005. Fought & lived over 2 1/2 years with multiple lines of treatment.

    Post describing our journey: http://cancerforums.net/viewtopic.ph...er=asc&start=0

    Left my embrace to live with our Heavenly Father in October of 2007 and now breathes with ease forever. I will miss this gentle, giving soul with the easy smile for the rest of my days, but have faith we will be together again. He's just getting a little break from me!

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    Aug. 27, 2011. Pfizer won U.S. approval to sell a drug targeted at a form of lung cancer caused by a gene defect, as the world’s largest drugmaker seeks tumor-fighting medicines to replace sales expected to be lost to generics.
    The treatment, crizotinib, was cleared five weeks ahead of schedule for patients with late-stage, non-small cell lung cancer with a rare genetic abnormality, the Food and Drug Administration said yesterday in a statement. Pfizer will sell the twice-a-day pill under the name Xalkori .
    Last edited by lancepeace; 09-01-2011 at 01:49 PM. Reason: removed expired link
    DOB Sept. 1947. Prostate cancer Gleason 7 (3+4), PSA 5 in Oct 2010. Cryoablation Jan. 2011. Had some complications.
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  3. #3
    Administrator Top User pbj11's Avatar
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    NEW DRUG APPROVED FOR TREATMENT OF NON SMALL CELL LUNG CANCER IN SPECIFIC PATIENT POPULATION

    Xalkori (crizotinib) Available for Lung Cancer Patients with the ALK Mutation
    Washington, D.C. [Thursday, September 1, 2011]—Lung Cancer Alliance (LCA) applauds the Food and Drug Administration (FDA) approval of Xalkori (crizotinib) with non-small cell lung cancer (NSCLC) who are ALK positive. The drug was approved based on data from two clinical trials, both of which showed a significant increase in overall survival.


    Xalkori targets the echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK) mutation. According to the FDA, the mutation is only present in 1-7% of people with NSCLC, primarily those diagnosed with adenocarcinoma.


    "This is exciting news," said LCA President & CEO, Laurie Fenton Ambrose. "Personalized medicine is where we are headed for lung cancer treatments. This is one of the first steps towards identifying medications that help select populations of people. We must continue to identify other mutations and find drugs that treat them to finally see cures for lung cancer."


    "I was enrolled in the phase I trial for this drug," said Linnea Duff, NH resident and longtime lung cancer survivor. "
    At the time I began the trial, I was hoping to have my life extended for a few months. Instead, I got three more years to spend with my family and friends. In addition, because this was a targeted therapy, the side effects were minimal and my quality of life during this time has been remarkable."
    Xalkori has shown a life changing response to lung cancer in those patients who are ALK positive. Lung Cancer Alliance encourages lung cancer patients to discuss genetic testing options with their health care team.


    It is important to note that many genetic mutations have been identified but not all have drugs to target the mutations at this time. With continued focus from researchers and increased participation in clinical trials, more and more of these personalized therapies will become available.

    For more information about clinical trials, please call the Lung Cancer Clinical Trial Matching Service, 800-698-0931.
    Husband diagnosed with NSCLC Stage IV in 3/2005. Fought & lived over 2 1/2 years with multiple lines of treatment.

    Post describing our journey: http://cancerforums.net/viewtopic.ph...er=asc&start=0

    Left my embrace to live with our Heavenly Father in October of 2007 and now breathes with ease forever. I will miss this gentle, giving soul with the easy smile for the rest of my days, but have faith we will be together again. He's just getting a little break from me!

  4. #4
    Administrator Top User pbj11's Avatar
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    MORE INFO ON CRIZOTINIB MAY BE FOUND IN THIS THREAD: http://www.cancerforums.net/threads/...ght=crizotinib
    Husband diagnosed with NSCLC Stage IV in 3/2005. Fought & lived over 2 1/2 years with multiple lines of treatment.

    Post describing our journey: http://cancerforums.net/viewtopic.ph...er=asc&start=0

    Left my embrace to live with our Heavenly Father in October of 2007 and now breathes with ease forever. I will miss this gentle, giving soul with the easy smile for the rest of my days, but have faith we will be together again. He's just getting a little break from me!

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    Starting Xalkori

    My brother will be starting on Xalkori (crizotinib) this week.

    His first ALK test was negative, but the new test by Pfizer (FISH test) came back positive. His oncologist always suspected an ALK mutation based on his age (51), non-smoker, etc.

    Excited to see what this drug will do!

  6. #6
    Administrator Top User pbj11's Avatar
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    Wow -- this is great news! We'll all be excited to see how well this new therapy works too.

    God bless him and keep us updated.

    PBJ
    Husband diagnosed with NSCLC Stage IV in 3/2005. Fought & lived over 2 1/2 years with multiple lines of treatment.

    Post describing our journey: http://cancerforums.net/viewtopic.ph...er=asc&start=0

    Left my embrace to live with our Heavenly Father in October of 2007 and now breathes with ease forever. I will miss this gentle, giving soul with the easy smile for the rest of my days, but have faith we will be together again. He's just getting a little break from me!

  7. #7
    Top User emilyloveslime's Avatar
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    Exciting! I'm hoping for a positive for my boyfriend too. He came back negative beforehand but hopefully this new test will provide new results! Crossing my fingers for him to respond well to the new pill

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    Xalkori working

    An update:

    My brother has been on Xalkori for 6 weeks. Most notable side effects have been digestion issues (nausea and diarrhea). And the COST.

    PET scan done this week shows remarkable results. Doctor was surprised it has done this much in just the first 6 weeks. The originating tumor in the lung (was 2.5cm after 10 rounds of chemo) is now no longer a solid mass: it's breaking apart and dying. And the cancer spot in his hip bone is now very small and showed up blue (not bright green) on the PET scan.

    Continuing on Xalkori for another 9 weeks and then do another PET scan.

    I hope others are getting good results!

  9. #9
    Administrator Top User pbj11's Avatar
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    Oh my --- that IS fantastic results! I hope this ends up like Tarceva has for some others, where he can be on it for a long time.

    Terrific news and thanks so much for sharing! Congrats to your brother.

    God bless,
    PBJ
    Husband diagnosed with NSCLC Stage IV in 3/2005. Fought & lived over 2 1/2 years with multiple lines of treatment.

    Post describing our journey: http://cancerforums.net/viewtopic.ph...er=asc&start=0

    Left my embrace to live with our Heavenly Father in October of 2007 and now breathes with ease forever. I will miss this gentle, giving soul with the easy smile for the rest of my days, but have faith we will be together again. He's just getting a little break from me!

  10. #10
    Top User maryaz's Avatar
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    Wow, this is one of those things that you sure hope keeps working. Keep us posted. I gather your brother has had no other treatments. I did look back to see what he was dx'd with and below is your post from March 26th. This is why it is nice to have what the person's dx is under the signature part. I am up on this one. Will check it out. I know I read about it though.
    "My brother (age 51) was recently diagnosed with Stage IV non-small cell lung cancer (adenocarcinoma). Oncologist believes it has spread to lymph nodes outside his lung and also his hip..."
    Husband (year of birth 1941) dx'd 2008 NSCLC - Squamous Cell Carcinoma
    Chemo and Radiation Treatments together. Allergic reaction to Taxol & Taxotere.
    The Story 2008 to 1/2011: http://www.cancerforums.net/about9079.html

    2010/2011: Returned & spread to lower lumbar bone/marrow. Stage 4.
    Chemo & Radiation together. Allergic reaction to Erbitux. Chemo was only Navelbine.
    The Story continues 2/2011: Story continues 2/2011: http://tinyurl.com/68qpmym

  11. #11
    Top User maryaz's Avatar
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    Quote Originally Posted by CancerStinks View Post
    My brother will be starting on Xalkori (crizotinib) this week.

    His first ALK test was negative, but the new test by Pfizer (FISH test) came back positive. His oncologist always suspected an ALK mutation based on his age (51), non-smoker, etc.

    Excited to see what this drug will do!
    Can anyone tell me what it is about the two different tests for the ALK. I see Emily's boyfriend also had a second test. I am pretty sure the Oncologist told my husband that he was also negative. I think this is from a test that was taken some time ago.

    Also my husbnd's Lung Cancer is Squamous Cell Carcinoma and he was a smoker. I don't want to miss anything that he might could use though. He has gone thru several chemos already. I hope someone knows about this. Thanks,
    Husband (year of birth 1941) dx'd 2008 NSCLC - Squamous Cell Carcinoma
    Chemo and Radiation Treatments together. Allergic reaction to Taxol & Taxotere.
    The Story 2008 to 1/2011: http://www.cancerforums.net/about9079.html

    2010/2011: Returned & spread to lower lumbar bone/marrow. Stage 4.
    Chemo & Radiation together. Allergic reaction to Erbitux. Chemo was only Navelbine.
    The Story continues 2/2011: Story continues 2/2011: http://tinyurl.com/68qpmym

  12. #12
    Top User emilyloveslime's Avatar
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    Hey Mary-
    Mike's test was just a retest. The first lab that the hospital went with had a 10% error rate. So they dropped that lab because of the error rates and went to a new one for testing, so they had him retested. We were crossing our fingers for an initial error on the first test, but it was a no go. I'm sorry that I can't be of much help!
    Boyfriend, 25, dx'ed Stage IV NSCLC 6/29/11. Malignant pleural effusion, liver/spine/lymph mets. Adenocarcinoma w/unknown primary! So confusing.

    Jul '11: 2 cycles Carboplatin/Alimta (failed)
    Oct '11: Docetaxol/ramucirumab/Xgeva/Neulasta
    Dec '12: Liver met growth
    Jan '13: 10+ brain mets, 2 wks of WBR
    Mar '13: CDK 4/6 inhibitor trial (failed)
    May '13: Tested ROS1+
    June '13: Xalkori clinical trial for ROS1+
    Aug '13: Liver mets gone, lung spots gone. Doing great so far!
    Mar '14: Leptomeningeal progression. Ommaya reservoir put in for intrathecal methotrexate.
    May '14: Tolerating chemo, hoping for good news...

    Blog: http://ros1positive.wordpress.com/

  13. #13
    Top User maryaz's Avatar
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    Thanks Emily. I thought maybe they had a new test or such as that. I couldn't imagine why though. My husband didn't have it either. I checked since I was last in here.
    Husband (year of birth 1941) dx'd 2008 NSCLC - Squamous Cell Carcinoma
    Chemo and Radiation Treatments together. Allergic reaction to Taxol & Taxotere.
    The Story 2008 to 1/2011: http://www.cancerforums.net/about9079.html

    2010/2011: Returned & spread to lower lumbar bone/marrow. Stage 4.
    Chemo & Radiation together. Allergic reaction to Erbitux. Chemo was only Navelbine.
    The Story continues 2/2011: Story continues 2/2011: http://tinyurl.com/68qpmym

  14. #14
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    Hi I'm new here. I just noticed this thread about xalkori. My mother is suppose to start taking this, she has this type of cancer. What none of the articles tell you is that this medicine costs $9,000.00 a month. The dr. office is going to help her with getting financial assistance from the company that makes this medicine. They said she shouldn't have any problem qualifying. It's a shame and these companies ought to be ashame to charge so much money for the medicines that are the most important, needed by the people that can't pay for them. Is anyone taking this med? How is it working for you?

 
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