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POW…there was further explaination by MattR (see link below) that if approved, a person would FIRST have to have PROGRESSED on IPI before getting PD1.
by MathewR » Tue Feb 18, 2014 3:04 pmThere is obviously a lot of excitement and anticipation regarding the approval of anti-PD-1 (me too!). As noted by others, from the media reports, it seems like Merck is in the lead with intent to file with the FDA by June. However, from everything I've seen on this, the approval will be limited to patients who have previously been treated with ipi (and progressed–see the quote pasted below from a recent Forbes interview with MRK's head of R&D). One might speculate that BMS will seek a similar limited approval–one that requires patients to first use its existing blockbuster, ipi. Folks should keep this in mind in developing their treatment plan in the coming months as being "ipi naive" may be an obstacle to receiving anti-PD-1 even after it is approved and available.-How can Merck file with the Food and Drug Administration for its programmed cell death receptor 1 (PD-1) drug, MK-3475 for melanoma before rival Bristol-Myers Squibb BMY +0.61%, which has presented more advanced data on its similar drug? Perlmutter says he won’t commment on Bristol’s data, but that MK-3475′s “breakthrough designation” helped speed communication with the FDA. The agency was willing to consider approve the drug because it shrinks tumors, without survival data, only if there’s a population of patients who have no other options. In this case, the FDA will view an application for MK-3475 in patients with advanced melanoma who have failed Bristol’s Yervoy. There’s about 9,000 patients with disease that advanced, and Yervoy helps about 10% of them, he says.
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POW…there was further explaination by MattR (see link below) that if approved, a person would FIRST have to have PROGRESSED on IPI before getting PD1.
by MathewR » Tue Feb 18, 2014 3:04 pmThere is obviously a lot of excitement and anticipation regarding the approval of anti-PD-1 (me too!). As noted by others, from the media reports, it seems like Merck is in the lead with intent to file with the FDA by June. However, from everything I've seen on this, the approval will be limited to patients who have previously been treated with ipi (and progressed–see the quote pasted below from a recent Forbes interview with MRK's head of R&D). One might speculate that BMS will seek a similar limited approval–one that requires patients to first use its existing blockbuster, ipi. Folks should keep this in mind in developing their treatment plan in the coming months as being "ipi naive" may be an obstacle to receiving anti-PD-1 even after it is approved and available.-How can Merck file with the Food and Drug Administration for its programmed cell death receptor 1 (PD-1) drug, MK-3475 for melanoma before rival Bristol-Myers Squibb BMY +0.61%, which has presented more advanced data on its similar drug? Perlmutter says he won’t commment on Bristol’s data, but that MK-3475′s “breakthrough designation” helped speed communication with the FDA. The agency was willing to consider approve the drug because it shrinks tumors, without survival data, only if there’s a population of patients who have no other options. In this case, the FDA will view an application for MK-3475 in patients with advanced melanoma who have failed Bristol’s Yervoy. There’s about 9,000 patients with disease that advanced, and Yervoy helps about 10% of them, he says.
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POW…there was further explaination by MattR (see link below) that if approved, a person would FIRST have to have PROGRESSED on IPI before getting PD1.
by MathewR » Tue Feb 18, 2014 3:04 pmThere is obviously a lot of excitement and anticipation regarding the approval of anti-PD-1 (me too!). As noted by others, from the media reports, it seems like Merck is in the lead with intent to file with the FDA by June. However, from everything I've seen on this, the approval will be limited to patients who have previously been treated with ipi (and progressed–see the quote pasted below from a recent Forbes interview with MRK's head of R&D). One might speculate that BMS will seek a similar limited approval–one that requires patients to first use its existing blockbuster, ipi. Folks should keep this in mind in developing their treatment plan in the coming months as being "ipi naive" may be an obstacle to receiving anti-PD-1 even after it is approved and available.-How can Merck file with the Food and Drug Administration for its programmed cell death receptor 1 (PD-1) drug, MK-3475 for melanoma before rival Bristol-Myers Squibb BMY +0.61%, which has presented more advanced data on its similar drug? Perlmutter says he won’t commment on Bristol’s data, but that MK-3475′s “breakthrough designation” helped speed communication with the FDA. The agency was willing to consider approve the drug because it shrinks tumors, without survival data, only if there’s a population of patients who have no other options. In this case, the FDA will view an application for MK-3475 in patients with advanced melanoma who have failed Bristol’s Yervoy. There’s about 9,000 patients with disease that advanced, and Yervoy helps about 10% of them, he says.
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