Monday, December 21, 2015

Anti-PD1 products FDA approved as first line treatment for melanoma

We have long known that response rates of 40% to anti-PD1 (Pembrolizumab/Keytruda  and Nivolumab/Opdivo) are much higher than the 15% response rates attained by Ipilimumab/Yervoy with much fewer side effects caused by anti-PD1 as well.  Even so, both anti-PD1 products (Pembro in September of 2014 and Nivo that December), were FDA approved as second line treatments for melanoma patients....meaning:  patients could only be given the drugs after they had failed to respond to ipi as well as BRAFi, if they were BRAF positive.  In October of 2015, the Nivo/ipi combo was FDA approved (with its much higher response rate of 50+%, and increased side effect profile to match).  In November, Nivo/Opdivo was finally approved as first line for advanced melanoma patients, albeit with a few caveats: Nivo/Opdivo approved as first line for melanoma

Just this month, Pembro/Keytruda has been approved for the same:
FDA approves Keytruda for first line treatment of metastatic melanoma
As best as I can determine, BRAF status is not a defining requirement, though "advanced" melanoma is, but it may be used in "untreated" patients.

But, as always seems to be the case with melanoma, there is a catch.  So far, the only treatment (other than inteferon) FDA approved as adjuvant (meaning available for Stage 3 or 4 patients who have no current, measurable disease...having had their lesions zapped with radiation or removed surgically) is ipi/Yervoy.  Ipi approved as adjuvant treatment for melanoma patients

However, all the additional FDA approvals do give me hope for NED patients.  Now that these drugs are FDA approved in their varied capacities, physicians have greater freedom to prescribe them as they see fit.  Hopefully, insurance payers will see the wisdom of providing coverage for more effective meds with fewer side effects over those with less efficacy and greater side effects (read costs)- even if they only look at it with an eye to their bottom line!  I will look at it as a way to ameliorate human suffering and combat a vicious disease. - c

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