Any ideas when Nivolumab will be FDA approved?

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1/25/2014 7:12am
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I've heard this year.   What have you heard?

Just yesterday, there was an interesting article about the stock price of Bristol-Meyers Squib http://news.investors.com/technology/012414-687534-bmy-stock-up-then-down-after-q4-report.htm The article reported that the share price dropped considerably because investors think that it's going to take the company longer to bring Nivo to market than they had expected.

From what I can tell, the problem (from our point of view) is that BMS thinks that Nivo will be effective against several different types of cancer including lung cancer and kidney cancer. They also want to find out which genetic markers are associated with responsiveness or non-responsiveness to the treatment. This means that the company's clinical trial resources are stretched thin and melanoma is not necessarily their top priority.

Caatherine Poole of the MIF still thinks late 2014 or early 2015, but nobody can say for sure. 

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?  

No, I haven't but I'll be on the lookout.  Wouldn't it be great to have two more drugs on our list!   I'm not braf positive, so my list is a little shorter.....

Terrie

One of my doctors thinks in 2014 but another doctor is really not convinced.   Frustrating but interesting too!

Terrie

 

Mayo Clinic told us hopefully March.

Mayo told you March!???  I hope so!  

Thank you and all my best to you!

Terrie

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. 

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.”

 
 
Bristol-Myers Squibb Not Ready to Push Through With Cancer Drug Trial, Experiences Lowest Stock Drop In 17 Months

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By Estel Grace Masangkay

Bristol-Myers Squibb (BMS) experienced its lowest stock drop (5.6%) in 17 months after the company announced it was not ready to push through with its investigational combination cancer treatment trial. The trial included BMS’ highest prospect lung cancer drug nivolumab and Yervoy.

Nivolumab is being tested as an investigational treatment for lung, skin, and kidney cancers, among others. The drug could be used as a monotherapy or in combination with Yervoy, BMS’ first immune-based cancer drug. Yervoy is already available in the market.

The combination presented a strong possibility to develop a powerful therapy against cancer. Investors had been closely following the drug trials and awaiting the company’s move as to when it will push the trial to its final stages.  Already, the Yervoy-nivolumab combination therapy has led the company’s shares to a 42 percent gain in the last 12 months.

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.”

Analysts said investors put high valuation on the company’s top prospect’s success. Judson Clark, an analyst with Edward Jones and Co., said, “We’ve got a hold rating on Bristol, because we’ve got a valuation that can’t be supported without overly strong nivo and Yervoy sales... At this point it looks like the estimates have almost fully baked in success.”

The company is deemed the furthest along in cancer drugs research programs. BMS announced in November last year that it was ending research in diabetes, neuroscience, and hepatitis C in order to focus on new generation immune-based cancer therapies. Clark said the company’s move made sense, “When you realize you are the furthest down the path of these cancer drugs, it makes sense to make that your focus.”

The company said lower costs from the November research overhaul won’t affect results until late 2014. BMS said it anticipates increased spending to help introduce novel cancer treatments despite stock drops due to investor uncertainties.

Source: http://www.bloomberg.com/news/2014-01-24/bristol-myers-beats-earnings-estimates-on-drug-sales-gain.html

 

Advocate for your own treatment.. Stage 4 Melanoma NED Surgery,Radiation, Temodar 300Mg July 2009-March 2010, then Thorocotomy...now "Phase I Study of Anti-PD-1 Human Monoclonal Antibody MDX-1106 and Vaccine Therapy"

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. 

Thank you, Lynn, for important information.  Learned a lot!

Terrie

BMS announced today that they'll be making their official application to the FDA for approval of their PD-1 checkpoint inhibitor nivolumab this fall.  Of lesser importance, they're going with the brand name Opdivo.  MarketWatch article here:
 
Bristol-Myers Squibb Announces Plans for Third Quarter Submission of a Biologics License Application for Opdivo®(nivolumab), an Investigational PD-1 Immune Checkpoint Inhibitor, for Previously Treated Advanced Melanoma
 
 
Interesting because many expected that BMS would wait until early 2015 to submit.  They'll be seeking approval similar to the way Merck's approval will likely come through and the EAP's are being constructed, namely that it will require prior failure with ipilimumab (Yervoy), and for BRAF-positive patients, prior BRAF-targeted therapy.  First-line approval would then come later once the final Phase III trials are completed.
 
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