Lehigh Valley Hospital – Compassionate use of Nivolumab + Ip

[PhillyRed]

Catherine,

I heard on TV last night that Lehigh Valley Hospital in the Allentown/Bethlehem, PA area has just gotten federal approval to offer Nivolumab (BMS’ anti-PD1 drug) and ipilimumab to Stage IV melanoma patients in a compassionate use basis. A Dr. Nair was quoted in the TV announcement. Have you heard anything about it?

[Catherine Poole]

No I haven’t. There is only the Expanded Access Program (which isn’t compassionate use) that opened last week, but officially opened in any centers that I know of yet. So I will inquire to hear more. I think the media often get these things confused. As far as I know single compassionate use is rare and beyond that non existent!

[RJoeyB]

I saw a story on channel 6 Philadelphia news about it one night last week, too, but the video was never posted to the 6ABC website. The story was kind of vague, but there was a media event at LVHN that day and they posted an article to their own site about it here:

http://news.lvhn.org/2014/05/22/melanoma-event-celebrates-local-peoples-survival-and-promotes-access-to-clinical-trials/” class=”bbcode_url”>http://news.lvhn.org/2014/05/22/melanoma-event-celebrates-local-peoples-survival-and-promotes-access-to-clinical-trials/

The article seems to be discussing their participation as a trial site in the current BMS nivo + ipi trial, however, near the end of the article it also mentions that “going forward”, they’ll be a site for a “compassionate use” program for nivo alone.

ClinicalTrials.gov also has a relatively new (less than two weeks old) posting for an EAP for nivo (single-agent, not with ipi).

https://clinicaltrials.gov/ct2/show/NCT02142218” class=”bbcode_url”>https://clinicaltrials.gov/ct2/show/NCT02142218

The criteria read similar to Merck’s anti-PD-1 EAP for lambro, i.e. previously tried and failed ipi, and if BRAF-positive, also tried and failed a BRAF inhibitor.

[Catherine Poole]

Yes the expanded access for nivo (BMS version of PD1) is opening soon. It is not to be confused with compassionate use though. You must have failed both iPi and braf drugs if braf positive.

[RJoeyB]

Catherine Poole wrote:

It is not to be confused with compassionate use though.

Most of the things I’ve read over the years and some of the doctors I’ve talked with seem to use “expanded access” and “compassionate use” interchangably; even the FDA’s website equates them:

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm” class=”bbcode_url”>http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm

“Expanded access” is certainly a less harsh term than “compassionate use”, sounding less like a last ditch effort for someone who is out of FDA-approved options. The way I’ve always interpreted the two was that an EAP was a formalized program to basically provide compassionate use of a treatment outside the context of a trial to many patients, often at multiple sites, while compassionate use is more of an individual request from a patient (or doctor) for access to the same. Splitting hairs perhaps.

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