› Forums › General Melanoma Community › FDA Approves Opdivo and Yervoy Combination
- This topic has 15 replies, 5 voices, and was last updated 8 years, 7 months ago by JoshF.
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- October 1, 2015 at 1:01 pm
Great news! Today the FDA granted approval for the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for patients with previously untreated advanced melanoma! Read the MRF's statement to learn why this is an important milestone and what this means for the melanoma community: http://www.melanoma.org/about-us/news-press-room/press-releases/fda-approves-opdivo-and-yervoy-combination-advanced-melanoma
– Lauren, MRF
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- October 1, 2015 at 1:27 pm
This is great news but is this only for patients with untreated advanced melanoma? What about the rest of us who may want to try this combination drugs if the current monotherapy we are using is no longer effective?
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- October 1, 2015 at 5:12 pm
I think insurance will be open to covering the combination even after monotherapy, but it may depend on the monotherapy.
If you are currently on ipi, or close to the last infusion, then I suspect most doctors would recommend going with anti-PD1 as monotherapy. If it is targeted therapy you should have no trouble at all. If you have been on anti-PD1 the picture is less clear.
This approval is based on a study of the combination in comparison to ipi, and only in patients who are BRAF wild-type. Another study is underway comparing ipi vs. nivo vs. the combination, and patients in the study regardless of BRAF status. The FDA hearing for that study is not until January, but the early data is already published. Based on that data, I don't believe the insurance companies will balk at paying for the combination regardless of BRAF status.
If you and your treatment team feel that the combination is the best next step and are getting pushback from the insurance company the company has programs that can help you navigate those waters.
Tim–MRF
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- October 1, 2015 at 5:12 pm
I think insurance will be open to covering the combination even after monotherapy, but it may depend on the monotherapy.
If you are currently on ipi, or close to the last infusion, then I suspect most doctors would recommend going with anti-PD1 as monotherapy. If it is targeted therapy you should have no trouble at all. If you have been on anti-PD1 the picture is less clear.
This approval is based on a study of the combination in comparison to ipi, and only in patients who are BRAF wild-type. Another study is underway comparing ipi vs. nivo vs. the combination, and patients in the study regardless of BRAF status. The FDA hearing for that study is not until January, but the early data is already published. Based on that data, I don't believe the insurance companies will balk at paying for the combination regardless of BRAF status.
If you and your treatment team feel that the combination is the best next step and are getting pushback from the insurance company the company has programs that can help you navigate those waters.
Tim–MRF
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- October 1, 2015 at 5:12 pm
I think insurance will be open to covering the combination even after monotherapy, but it may depend on the monotherapy.
If you are currently on ipi, or close to the last infusion, then I suspect most doctors would recommend going with anti-PD1 as monotherapy. If it is targeted therapy you should have no trouble at all. If you have been on anti-PD1 the picture is less clear.
This approval is based on a study of the combination in comparison to ipi, and only in patients who are BRAF wild-type. Another study is underway comparing ipi vs. nivo vs. the combination, and patients in the study regardless of BRAF status. The FDA hearing for that study is not until January, but the early data is already published. Based on that data, I don't believe the insurance companies will balk at paying for the combination regardless of BRAF status.
If you and your treatment team feel that the combination is the best next step and are getting pushback from the insurance company the company has programs that can help you navigate those waters.
Tim–MRF
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- October 1, 2015 at 6:30 pm
What about previous Inteferon treatment?
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- October 1, 2015 at 6:30 pm
What about previous Inteferon treatment?
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- October 1, 2015 at 6:30 pm
What about previous Inteferon treatment?
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