Seems that Merck is moving more aggressively for approval of their Anti-PD-1 drug (MK 3475). I suspect this will be first to hit the market.  Has anyone heard whether there have been any trials to test whether Merck's product has a similar added benefit when combined with IPI as Nivo does?  

Seems that Merck is moving more aggressively for approval of their Anti-PD-1 drug (MK 3475). I suspect this will be first to hit the market.  Has anyone heard whether there have been any trials to test whether Merck's product has a similar added benefit when combined with IPI as Nivo does?  

Seems that Merck is moving more aggressively for approval of their Anti-PD-1 drug (MK 3475). I suspect this will be first to hit the market.  Has anyone heard whether there have been any trials to test whether Merck's product has a similar added benefit when combined with IPI as Nivo does?  

Mayo Clinic told us hopefully March.

No one else seems to be saying March.

It was suggested to me by one person that, because BMS did a large compassionate use program for Yervoy for some time (months? I vaguely remember this happening) leading up to its FDA approval, that maybe BMS and/or MRK might consider doing something similar with PD-1. Can't count on that either but I hope so.

No one else seems to be saying March.

It was suggested to me by one person that, because BMS did a large compassionate use program for Yervoy for some time (months? I vaguely remember this happening) leading up to its FDA approval, that maybe BMS and/or MRK might consider doing something similar with PD-1. Can't count on that either but I hope so.

No one else seems to be saying March.

It was suggested to me by one person that, because BMS did a large compassionate use program for Yervoy for some time (months? I vaguely remember this happening) leading up to its FDA approval, that maybe BMS and/or MRK might consider doing something similar with PD-1. Can't count on that either but I hope so.

Can't believe everything you read in the media, but it seems like BMS is prioritizing Nivo approval for lung cancer over melanoma.  Merck has stated that they intend to file a rolling application by the end of June, first focusing on ipi-treated melanoma patients.  Hopefully one or both of these companies will look to make a major annoucement in conjunction with the annual ASCO conference in June, but that's just me speculating.  The issue with compassionate use (again me speculating) is that both if these companies are running large trials focusing on different cancers.  Likely already a burden on the supply of the drugs.  My impression is that the clinicians do not have good information on the approval date (which is presumably kept under tight controls for investor/securities law considerations).  To be further "wet blanket" here (sorry), keep in mind that "approval" does not mean that the drugs are instantly available.  I started on the GSK combo in early August and the drugs weren't easy to obtain then–even though they were approved in May.  Following approval, the companies need to ramp up manfacturing and get the drugs out to specialty pharmacies.  Insurance company approval for new drugs can also take additional time.  Like you, I'm hoping for speedy approval and availability in 2014. 

Can't believe everything you read in the media, but it seems like BMS is prioritizing Nivo approval for lung cancer over melanoma.  Merck has stated that they intend to file a rolling application by the end of June, first focusing on ipi-treated melanoma patients.  Hopefully one or both of these companies will look to make a major annoucement in conjunction with the annual ASCO conference in June, but that's just me speculating.  The issue with compassionate use (again me speculating) is that both if these companies are running large trials focusing on different cancers.  Likely already a burden on the supply of the drugs.  My impression is that the clinicians do not have good information on the approval date (which is presumably kept under tight controls for investor/securities law considerations).  To be further "wet blanket" here (sorry), keep in mind that "approval" does not mean that the drugs are instantly available.  I started on the GSK combo in early August and the drugs weren't easy to obtain then–even though they were approved in May.  Following approval, the companies need to ramp up manfacturing and get the drugs out to specialty pharmacies.  Insurance company approval for new drugs can also take additional time.  Like you, I'm hoping for speedy approval and availability in 2014. 

I'll be the wet blanket…   "But BMS said it was not ready to proceed with the long-awaited final stage of the trials. New York-based BMS R&D head Francis Cuss said, “Based on our assessment of the preliminary data, we will continue the cohorts of patients before beginning a registrational study… We’ll certainly know a lot more about nivolumab a year from now.”

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I'll be the wet blanket…   "But BMS said it was not ready to proceed with the long-awaited final stage of the trials. New York-based BMS R&D head Francis Cuss said, “Based on our assessment of the preliminary data, we will continue the cohorts of patients before beginning a registrational study… We’ll certainly know a lot more about nivolumab a year from now.”

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Thanks, Lynn. Since BMS is attempting to develop anti-PD1 to treat a number of different cancers, I can understand why data accrual and the FDA application process may take longer than if they were just going for melanoma approval. You're not a wet blanket– it's better that we know the truth than that we make our treatment decisions thinking that anti-PD1 will be FDA approved any day now. 

Not FDA approved, no news on Europe (I'm Dutch) but it's now in Japan!

http://www.fiercebiotech.com/story/anti-pd-1-cancer-star-nivolumab-wins-worlds-first-regulatory-approval/2014-07-07

Not FDA approved, no news on Europe (I'm Dutch) but it's now in Japan!

http://www.fiercebiotech.com/story/anti-pd-1-cancer-star-nivolumab-wins-worlds-first-regulatory-approval/2014-07-07

Not FDA approved, no news on Europe (I'm Dutch) but it's now in Japan!

http://www.fiercebiotech.com/story/anti-pd-1-cancer-star-nivolumab-wins-worlds-first-regulatory-approval/2014-07-07

Thanks, Lynn. Since BMS is attempting to develop anti-PD1 to treat a number of different cancers, I can understand why data accrual and the FDA application process may take longer than if they were just going for melanoma approval. You're not a wet blanket– it's better that we know the truth than that we make our treatment decisions thinking that anti-PD1 will be FDA approved any day now. 

Thanks, Lynn. Since BMS is attempting to develop anti-PD1 to treat a number of different cancers, I can understand why data accrual and the FDA application process may take longer than if they were just going for melanoma approval. You're not a wet blanket– it's better that we know the truth than that we make our treatment decisions thinking that anti-PD1 will be FDA approved any day now. 

I'll be the wet blanket…   "But BMS said it was not ready to proceed with the long-awaited final stage of the trials. New York-based BMS R&D head Francis Cuss said, “Based on our assessment of the preliminary data, we will continue the cohorts of patients before beginning a registrational study… We’ll certainly know a lot more about nivolumab a year from now.”

Request Information

Can't believe everything you read in the media, but it seems like BMS is prioritizing Nivo approval for lung cancer over melanoma.  Merck has stated that they intend to file a rolling application by the end of June, first focusing on ipi-treated melanoma patients.  Hopefully one or both of these companies will look to make a major annoucement in conjunction with the annual ASCO conference in June, but that's just me speculating.  The issue with compassionate use (again me speculating) is that both if these companies are running large trials focusing on different cancers.  Likely already a burden on the supply of the drugs.  My impression is that the clinicians do not have good information on the approval date (which is presumably kept under tight controls for investor/securities law considerations).  To be further "wet blanket" here (sorry), keep in mind that "approval" does not mean that the drugs are instantly available.  I started on the GSK combo in early August and the drugs weren't easy to obtain then–even though they were approved in May.  Following approval, the companies need to ramp up manfacturing and get the drugs out to specialty pharmacies.  Insurance company approval for new drugs can also take additional time.  Like you, I'm hoping for speedy approval and availability in 2014. 

Mayo Clinic told us hopefully March.

Mayo Clinic told us hopefully March.