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Prospects for ipilimumab
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Prospects for ipilimumab

› Forums › General Melanoma Community › Prospects for ipilimumab

  • Post
    • January 5, 2011 at 6:10 pm
    PeterO
    Participant

      Watching what's happening with the Avastin controversy in breast cancer makes me wonder what the prospects are that FDA will ultimately decline to approve Yervoy (as I guess ipi is being called now) for advanced melanoma. What's the speculation? The astronomical prices for cancer drugs is bound for a head-on collision with Obamacare.

      Watching what's happening with the Avastin controversy in breast cancer makes me wonder what the prospects are that FDA will ultimately decline to approve Yervoy (as I guess ipi is being called now) for advanced melanoma. What's the speculation? The astronomical prices for cancer drugs is bound for a head-on collision with Obamacare.

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    • Replies
        • January 6, 2011 at 4:28 am
        Jim in Denver
        Participant

          Hi Peter,

          As a participant in a trail at MD Anderson involving high dose Ipi and Temador, I follow the published information but also ask my Oncologist questions about the FDA approval process.  The FDA postponed its public hearing and asked for more study data last fall, as you have probably seen.  This delay does not mean that approval is less likely for Ipi, but  indicate that FDA is being thorough in its process.  They don't approve many new drugs annually – a dozen or less.  Approval is expected no later than midyear, and possibly as early as April.  What dosage will be approved is not certain, but most likely the "low dose" – 3 mg/kg, and for Stage IV patients initially.  

          The relevance of Avastin at present to Ipi relates to pricing upon approval, which will be similar to Avastin.  Cost may be an issue depending on one's insurer and coverage,   No comment on your editorializing about the health insurance reform initiated by Congress in 2010, except to observe that the industry trade group for drug companies (PHARMA) was one of the primary advocates of the reform bill, so they obviously believe it will not harm them much if at all.

          Best Wishes,

          Jim

          • January 6, 2011 at 4:28 am
          Jim in Denver
          Participant

            Hi Peter,

            As a participant in a trail at MD Anderson involving high dose Ipi and Temador, I follow the published information but also ask my Oncologist questions about the FDA approval process.  The FDA postponed its public hearing and asked for more study data last fall, as you have probably seen.  This delay does not mean that approval is less likely for Ipi, but  indicate that FDA is being thorough in its process.  They don't approve many new drugs annually – a dozen or less.  Approval is expected no later than midyear, and possibly as early as April.  What dosage will be approved is not certain, but most likely the "low dose" – 3 mg/kg, and for Stage IV patients initially.  

            The relevance of Avastin at present to Ipi relates to pricing upon approval, which will be similar to Avastin.  Cost may be an issue depending on one's insurer and coverage,   No comment on your editorializing about the health insurance reform initiated by Congress in 2010, except to observe that the industry trade group for drug companies (PHARMA) was one of the primary advocates of the reform bill, so they obviously believe it will not harm them much if at all.

            Best Wishes,

            Jim

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