So many have been terribly disappointed with the FDA requirements that you must first fail ipilimumab (Yervoy) as well as BRAF inhibitors, if your melanoma is BRAF positive, BEFORE you can be given Pembrolizumab (Keytruda)...at least if you want insurance to pay for it...and at $12,500 per month/$150,000 per year, I don't know who could afford that price tag on their own!!!
But here's what the experts say about what is coming with anti-PD1 drugs in the future!!!!
Although pembrolizumab
was approved in the second-line setting, melanoma experts believe that
the PD-1 blockers have a bright future in the first-line setting. “With
pembrolizumab, patients have a 25% to 35% response rate,” Dr. Weber
said. “If you are a BRAF wild-type patient, the maximum
[response rate] with ipilimumab is 15% to 20%.” He pointed out that the
FDA and the European Medicines Agency will only approve a drug in a
setting that is supported by data, and so far, Merck has only submitted
second-line data. This, however, will change.
“There is an ongoing pembrolizumab versus ipilimumab trial in
treatment-naive patients. There is a first-line nivolumab trial:
ipilimumab versus nivolumab versus combo ipilimumab and nivolumab,” Dr.
Weber said. “Each trial has an active-control arm (not placebo), so we
are going to be waiting a little bit to see the results, but if those
trials are positive, which I feel confident they both will be, the FDA
will approve the anti–PD-1 drugs in the front-line [setting]. In the
future, I would bet you good money that everybody is going to use PD-1
drugs first and ipilimumab later.”
Check out this link from Clinical Oncology News, October 2014...and read it for yourself!
PD-1 Blocker Class Will Shake Up Melanoma Treatment
Fingers crossed that anti-PD1 as a first line drug for melanoma will be a reality sooner rather than later!!! Best - c
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