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Approval of ipi

Forums Cutaneous Melanoma Community Approval of ipi

  • Post
    mrf
    Keymaster

    The FDA just announced that they have approved Yervoy "ipi" for unresectable and metastatic melanoma.  This is the first time a drug has been approved for melanoma in 13 years, so great news!

    Here's the announcement:

    FDA NEWS RELEASE

    The FDA just announced that they have approved Yervoy "ipi" for unresectable and metastatic melanoma.  This is the first time a drug has been approved for melanoma in 13 years, so great news!

    Here's the announcement:

    FDA NEWS RELEASE

    (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

    For Immediate Release: March 25, 2011

    Media Inquiries: Erica Jefferson, 301-796-4988, [email protected]

    Consumer Inquiries: 888-INFO-FDA

    FDA approves new treatment for a type of late-stage skin cancer

    Melanoma patients lived longer with treatment

    The U.S. Food and Drug Administration today approved Yervoy (ipilimumab) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.

    Melanoma is the leading cause of death from skin disease. An estimated 68,130 new cases of melanoma were diagnosed in the United States during 2010 and about 8,700 people died from the disease, according to the National Cancer Institute.

    "Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient's life," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment."

    Yervoy is a monoclonal antibody that blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4. CTLA-4 may play a role in slowing down or turning off the body's immune system, affecting its ability to fight off cancerous cells. Yervoy may work by allowing the body's immune system to recognize, target, and attack cells in melanoma tumors. The drug is administered intravenously.

    Yervoy's safety and effectiveness were established in a single international study of 676 patients with melanoma. All patients in the study had stopped responding to other FDA-approved or commonly used treatments for melanoma. In addition, participants had disease that had spread or that could not be surgically removed.

    The study was designed to measure overall survival, the length of time from when this treatment started until a patient's death. The randomly assigned patients received Yervoy plus an experimental tumor vaccine called gp100, Yervoy alone, or the vaccine alone.

    Those who received the combination of Yervoy plus the vaccine or Yervoy alone lived an average of about 10 months, while those who received only the experimental vaccine lived an average of 6.5 months.

    Common side effects that can result from autoimmune reactions associated with Yervoy use include fatigue, diarrhea, skin rash, endocrine deficiencies (gland or hormone), and inflammation of the intestines (colitis). Severe to fatal autoimmune reactions were seen in 12.9 percent of patients treated with Yervoy.When severe side effects occurred, Yervoy was stopped and corticosteroid treatment was started. Not all patients responded to this treatment. Patients who did respond in some cases did not see any improvement for several weeks.

    Due to the unusual and severe side effects associated with Yervoy, the therapy is being approved with a Risk Evaluation and Mitigation Strategy to inform health care professionals about these serious risks. A medication guide will also be provided to patients to inform them about the therapy's potential side effects.

    Yervoy is marketed by New York City-based Bristol-Myers Squibb.

    For more information:

    FDA: Office of Oncology Drug Products

    http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

    FDA: Approved Risk Evaluation and Mitigation Strategies (REMS)

    http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

    FDA: Approved Drugs: Questions and Answers

    http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

    NCI: Melanoma

    http://www.cancer.gov/cancertopics/types/melanoma

    CDC: Skin Cancer

    http://www.cdc.gov/cancer/skin/

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  • Replies
      killmel
      Participant

      Hi Tim,

      I am not currently of IPI, but my doctor is recommending IPI are a treatment for me.

      Now that IPI has been approved, how long does it take for IPI  to be available to be sold to patients NOT in compassionate use trial orant clinical trial using IPI??

      Also, any idea how long it takes insurance companies to approve a drug to be covered under patients medical benefits?

      Did the FDA approve IPI for stage 3 & 4?

      Thanks for your response & continuing tohelpus.

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      killmel
      Participant

      Hi Tim,

      I am not currently of IPI, but my doctor is recommending IPI are a treatment for me.

      Now that IPI has been approved, how long does it take for IPI  to be available to be sold to patients NOT in compassionate use trial orant clinical trial using IPI??

      Also, any idea how long it takes insurance companies to approve a drug to be covered under patients medical benefits?

      Did the FDA approve IPI for stage 3 & 4?

      Thanks for your response & continuing tohelpus.

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      KatyWI
      Participant

      For those on the expanded access protocol in the US – I think this question came up a month or so ago – the consent for I signed stated, as I recall, that as of the date of approval, no more patients will be enrolled in the expanded access protocol.  However, BMS will provide Ipi for patients already enrolled for 30 more days.

      This doesn't really address the question posed above, about whether insurance companies will cover it, but it does ensure that anyone in the middle of therapy has a month to work on it with their insurance company.

      KatyWI

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      KatyWI
      Participant

      For those on the expanded access protocol in the US – I think this question came up a month or so ago – the consent for I signed stated, as I recall, that as of the date of approval, no more patients will be enrolled in the expanded access protocol.  However, BMS will provide Ipi for patients already enrolled for 30 more days.

      This doesn't really address the question posed above, about whether insurance companies will cover it, but it does ensure that anyone in the middle of therapy has a month to work on it with their insurance company.

      KatyWI

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      MaryD
      Participant

      Wonderful – and long overdue – news!  Hoping this is the first step in closing the long gap between available treatments for this insidious disease.

       

      Thanks for sharing .

       

      Mary

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      MaryD
      Participant

      Wonderful – and long overdue – news!  Hoping this is the first step in closing the long gap between available treatments for this insidious disease.

       

      Thanks for sharing .

       

      Mary

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      MichaelFL
      Participant

      First drug approved in 13 years, and it's approved on my birthday!

      Surprise! Hope I never need it!

      Michael

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      MichaelFL
      Participant

      First drug approved in 13 years, and it's approved on my birthday!

      Surprise! Hope I never need it!

      Michael

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      Jim M.
      Participant

      I'm so happy that Ipi has been approved. I had no idea what Ipi was until a few of you recommended that I jump on the trial with Ipi (john, I believe you were one). It was a step of faith (after much prayer) that I participated in this trial. It fills me with pride that I have been a small part of this history making event , as many of us have. The true pioneers were the ones who gave their lives as they succombed to the side effects of Ipi. My hope and prayer is this approval paves the way to impact and extend many many lives, even as Yervoy is being combined with other drugs to determine increased efficacy.

       God Bless,

       Jim M.

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      Jim M.
      Participant

      I'm so happy that Ipi has been approved. I had no idea what Ipi was until a few of you recommended that I jump on the trial with Ipi (john, I believe you were one). It was a step of faith (after much prayer) that I participated in this trial. It fills me with pride that I have been a small part of this history making event , as many of us have. The true pioneers were the ones who gave their lives as they succombed to the side effects of Ipi. My hope and prayer is this approval paves the way to impact and extend many many lives, even as Yervoy is being combined with other drugs to determine increased efficacy.

       God Bless,

       Jim M.

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