› Forums › Ocular Melanoma Community › New Drugs approved by FDA
- This topic has 36 replies, 8 voices, and was last updated 12 years, 6 months ago by
out4air.
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- May 29, 2013 at 7:04 pm
The FDA just approved two new drugs for treating metastatic melanoma. One is a BRAF inhibitor, similar to Zelboraf (vemurafenib). The other is a MEK inhibitor.
The MEK inhibitor can be used in patients whose tumors do not have the BRAF mutation, and also is being tested in uveal melanoma.
The biggest use, though will likely be in combining the BRAF and MEK inhibitors. Studies have shown that patients with the BRAF mutation who were treated with the combination had better response, longer response, and fewer side effects.
The FDA just approved two new drugs for treating metastatic melanoma. One is a BRAF inhibitor, similar to Zelboraf (vemurafenib). The other is a MEK inhibitor.
The MEK inhibitor can be used in patients whose tumors do not have the BRAF mutation, and also is being tested in uveal melanoma.
The biggest use, though will likely be in combining the BRAF and MEK inhibitors. Studies have shown that patients with the BRAF mutation who were treated with the combination had better response, longer response, and fewer side effects.
Here is the press release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm354199.htm
This is big news for the melanoma community, and a great step forward! We still have a long way to go, but two new drugs is a good thing.
Tim–MRF
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- May 29, 2013 at 7:20 pm
If it delays tumor growth 2-3 months, it's a breakthrough drug? Am I reading the data wrong?
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- May 29, 2013 at 7:50 pm
No, you are not reading the data wrong. This is by no means a magic bullet. It is another step forward, however, and some group of patients will have longer response times. When the BRAF and MEK are given together the median response time goes from 6 months for the BRAF alone to close to 11 months. Again, nothing close to a cure, but a step forward.
This is the disconnect between excitment over progress, and the harsh reality that the fight is still very, very tough. I do not mean to diminish the fact that a few extra months is not wonderful. Not bad, but not wonderful.
Tim–MRF
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- May 29, 2013 at 7:50 pm
No, you are not reading the data wrong. This is by no means a magic bullet. It is another step forward, however, and some group of patients will have longer response times. When the BRAF and MEK are given together the median response time goes from 6 months for the BRAF alone to close to 11 months. Again, nothing close to a cure, but a step forward.
This is the disconnect between excitment over progress, and the harsh reality that the fight is still very, very tough. I do not mean to diminish the fact that a few extra months is not wonderful. Not bad, but not wonderful.
Tim–MRF
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- May 29, 2013 at 7:50 pm
No, you are not reading the data wrong. This is by no means a magic bullet. It is another step forward, however, and some group of patients will have longer response times. When the BRAF and MEK are given together the median response time goes from 6 months for the BRAF alone to close to 11 months. Again, nothing close to a cure, but a step forward.
This is the disconnect between excitment over progress, and the harsh reality that the fight is still very, very tough. I do not mean to diminish the fact that a few extra months is not wonderful. Not bad, but not wonderful.
Tim–MRF
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- May 29, 2013 at 8:28 pm
Tim, thanks for the great news! That seems to be a rather speedy approval process, especially for the MEK drug. That's wonderful.
As for the median duration of response, it seems to me that some small percentage of people (10%? 15$%?) seem to have a very long duration response nto some particular drug. 10%-15% have long term response to radiation or to biochemo. Another 10%-15% have a long response to Zelboraf. Same with Yervoy and now BRAF+MEK–10%-15% of patients will be long-term responders to one of those treatments.
So while it would be great to have a treatment that cures melanoma in everyone, each new "effective" treatment is another arrow in the oncologist's quiver. Any given arrow might just be the one that YOU respond to long-term. So keep them arrows coming, folks! Hooray!!
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- May 29, 2013 at 8:28 pm
Tim, thanks for the great news! That seems to be a rather speedy approval process, especially for the MEK drug. That's wonderful.
As for the median duration of response, it seems to me that some small percentage of people (10%? 15$%?) seem to have a very long duration response nto some particular drug. 10%-15% have long term response to radiation or to biochemo. Another 10%-15% have a long response to Zelboraf. Same with Yervoy and now BRAF+MEK–10%-15% of patients will be long-term responders to one of those treatments.
So while it would be great to have a treatment that cures melanoma in everyone, each new "effective" treatment is another arrow in the oncologist's quiver. Any given arrow might just be the one that YOU respond to long-term. So keep them arrows coming, folks! Hooray!!
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- May 29, 2013 at 8:28 pm
Tim, thanks for the great news! That seems to be a rather speedy approval process, especially for the MEK drug. That's wonderful.
As for the median duration of response, it seems to me that some small percentage of people (10%? 15$%?) seem to have a very long duration response nto some particular drug. 10%-15% have long term response to radiation or to biochemo. Another 10%-15% have a long response to Zelboraf. Same with Yervoy and now BRAF+MEK–10%-15% of patients will be long-term responders to one of those treatments.
So while it would be great to have a treatment that cures melanoma in everyone, each new "effective" treatment is another arrow in the oncologist's quiver. Any given arrow might just be the one that YOU respond to long-term. So keep them arrows coming, folks! Hooray!!
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- May 29, 2013 at 9:22 pm
Thanks Tim. The article states “Mekinist, a MEK inhibitor, is approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations.”They didn’t specifically say that it is approved for BRAF wild-type, but I see that you said that iit can be used for patients without BRAF mutations. is this a mistake or omission on their part in the press release?
I ask because my wife has the NRAS mutation and this would be another option for her if correct. Would appreciate any clarification you can provide. Thanks!
Steve
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- May 29, 2013 at 9:22 pm
Thanks Tim. The article states “Mekinist, a MEK inhibitor, is approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations.”They didn’t specifically say that it is approved for BRAF wild-type, but I see that you said that iit can be used for patients without BRAF mutations. is this a mistake or omission on their part in the press release?
I ask because my wife has the NRAS mutation and this would be another option for her if correct. Would appreciate any clarification you can provide. Thanks!
Steve
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- May 29, 2013 at 9:22 pm
Thanks Tim. The article states “Mekinist, a MEK inhibitor, is approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations.”They didn’t specifically say that it is approved for BRAF wild-type, but I see that you said that iit can be used for patients without BRAF mutations. is this a mistake or omission on their part in the press release?
I ask because my wife has the NRAS mutation and this would be another option for her if correct. Would appreciate any clarification you can provide. Thanks!
Steve
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- May 30, 2013 at 4:05 pm
Steve:
The label only specifies the V600 mutation, but MEK has been tested in BRAF wild-type patients and I suspect that it will be used off-label for that patient population as a second or third line therapy. We will have to wait and see how this plays out. They are even testing MEK in uveal melanoma patients, and they don't have BRAF mutations or NRAS mutations.
I think that more focus for NRAS patients is being placed on PI3 kinase inhibitors, but will know more after ASCO this weekend.
Tim–MRF
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- May 30, 2013 at 4:05 pm
Steve:
The label only specifies the V600 mutation, but MEK has been tested in BRAF wild-type patients and I suspect that it will be used off-label for that patient population as a second or third line therapy. We will have to wait and see how this plays out. They are even testing MEK in uveal melanoma patients, and they don't have BRAF mutations or NRAS mutations.
I think that more focus for NRAS patients is being placed on PI3 kinase inhibitors, but will know more after ASCO this weekend.
Tim–MRF
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- May 30, 2013 at 4:05 pm
Steve:
The label only specifies the V600 mutation, but MEK has been tested in BRAF wild-type patients and I suspect that it will be used off-label for that patient population as a second or third line therapy. We will have to wait and see how this plays out. They are even testing MEK in uveal melanoma patients, and they don't have BRAF mutations or NRAS mutations.
I think that more focus for NRAS patients is being placed on PI3 kinase inhibitors, but will know more after ASCO this weekend.
Tim–MRF
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- May 30, 2013 at 1:08 pm
I have been on a combination trial of these two drugs for the past two years. I agree with Tim that the biggest use will likely be in combining the drugs. But I have questions:
Since the drugs are for now approved by the FDA only as single agents, will insurance companies and/or Medicare pay for both drugs when prescribed in combination?
Ethically, doctors are bound to prescribe the combination. But will insurers refuse to pay the extra $7000 – $8000 a month for the second drug?
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- May 30, 2013 at 1:53 pm
No, Harry, doctors are not "ethically bound" to prescribe the combination. My brother's doctor, for example, refused to prescibe anything off-label because if it didn't have FDA approval, it MIGHT have unexpected adverse effects. I'm still not sure if that was his personal philosophy or the VA's policy.
Nevertheless, the point people are making about insurance refusing to pay for BRAF and MEK at the same time is well taken and is a source of real concern. Catherine Poole at MIF says that the FDA will soon approve the combination, but who knows when? The other avenue is to get Medicare to approve paying for both at once– most (not all) insurance companies will eventually follow Mediare's lead.
And so the battle continues…
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- May 30, 2013 at 4:26 pm
Perhaps "ethically bound" is too loaded a term. But I suspect many doctors will prescribe the combination even before the FDA gives specific approval. I know my oncologist will.
Best wishes,
Harry
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- May 30, 2013 at 4:26 pm
Perhaps "ethically bound" is too loaded a term. But I suspect many doctors will prescribe the combination even before the FDA gives specific approval. I know my oncologist will.
Best wishes,
Harry
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- May 30, 2013 at 4:26 pm
Perhaps "ethically bound" is too loaded a term. But I suspect many doctors will prescribe the combination even before the FDA gives specific approval. I know my oncologist will.
Best wishes,
Harry
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- May 30, 2013 at 1:53 pm
No, Harry, doctors are not "ethically bound" to prescribe the combination. My brother's doctor, for example, refused to prescibe anything off-label because if it didn't have FDA approval, it MIGHT have unexpected adverse effects. I'm still not sure if that was his personal philosophy or the VA's policy.
Nevertheless, the point people are making about insurance refusing to pay for BRAF and MEK at the same time is well taken and is a source of real concern. Catherine Poole at MIF says that the FDA will soon approve the combination, but who knows when? The other avenue is to get Medicare to approve paying for both at once– most (not all) insurance companies will eventually follow Mediare's lead.
And so the battle continues…
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- May 30, 2013 at 1:53 pm
No, Harry, doctors are not "ethically bound" to prescribe the combination. My brother's doctor, for example, refused to prescibe anything off-label because if it didn't have FDA approval, it MIGHT have unexpected adverse effects. I'm still not sure if that was his personal philosophy or the VA's policy.
Nevertheless, the point people are making about insurance refusing to pay for BRAF and MEK at the same time is well taken and is a source of real concern. Catherine Poole at MIF says that the FDA will soon approve the combination, but who knows when? The other avenue is to get Medicare to approve paying for both at once– most (not all) insurance companies will eventually follow Mediare's lead.
And so the battle continues…
-
- May 30, 2013 at 1:08 pm
I have been on a combination trial of these two drugs for the past two years. I agree with Tim that the biggest use will likely be in combining the drugs. But I have questions:
Since the drugs are for now approved by the FDA only as single agents, will insurance companies and/or Medicare pay for both drugs when prescribed in combination?
Ethically, doctors are bound to prescribe the combination. But will insurers refuse to pay the extra $7000 – $8000 a month for the second drug?
-
- May 30, 2013 at 1:08 pm
I have been on a combination trial of these two drugs for the past two years. I agree with Tim that the biggest use will likely be in combining the drugs. But I have questions:
Since the drugs are for now approved by the FDA only as single agents, will insurance companies and/or Medicare pay for both drugs when prescribed in combination?
Ethically, doctors are bound to prescribe the combination. But will insurers refuse to pay the extra $7000 – $8000 a month for the second drug?
Tagged: ocular melanoma
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