Talk:Nivolumab

Compliments on Layout More pages should follow this example
I like the layout with non-tech, tech and market watch sections. Well done. Perhaps other similar pages could adopt a similar format.. — Preceding unsigned comment added by 88.51.81.22 (talk) 15:05, 3 June 2014 (UTC)

Chronic diseases
Is there any information that the drug could be used (off-label?) to treat and /or cure HIV and other chronic diseases?http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3731769/ could contain somewhat related info. Dmatteng (talk) 18:29, 4 September 2014 (UTC)

Pronunciation
The pronunciation currently given, "nye vol' ue mab", is disastrously ambiguous. Is that "nye" as in "nyet"? Or "nigh"? Is "ue" like "you", or the German u-umlaut? I'd correct it, but I don't know the correct pronunciation. Could someone who knows visit https://en.wikipedia.org/wiki/Wikipedia:Manual_of_Style/Pronunciation ? Peter (talk) 16:29, 7 May 2015 (UTC)

Kidney cancer
The kidney cancer section does not mention Nivolumab but is about comparing two drugs neither of which is related to Nivolumab. — Preceding unsigned comment added by 137.248.206.1 (talk) 17:45, 28 September 2015 (UTC)
 * I agree. One of the references also mentions a study comparing Nivolumab with everolimus that was stopped because Nivolumab was leading to better outcomes. But I don't feel qualified to rewrite the section from scratch, so I'm just going to remove it. 71.197.166.72 (talk) 04:26, 2 November 2015 (UTC)

Cost effectiveness - UK NICE - various cancers
UK NICE has decided it is cost effective (QALY < £30,000) for melanoma, but not for lung cancer (QALY £109k) The £68k-a-year skin cancer wonder drug on the NHS - Rod57 (talk) 12:09, 22 January 2016 (UTC)
 * good lord what a terrible link - an aggregator citing the Daily Mail. oy. Jytdog (talk) 18:27, 9 October 2016 (UTC)
 * Feel free to find one you like better. Anyway, now for Squamous NSCLC it seems to be £73,500 ($89,000) per QALY. DIVE.
 * There's probably an RS somewhere we could use for cost-effectiveness in the main article. - Rod57 (talk) 12:00, 18 October 2016 (UTC)
 * "It is available on the NHS to lung cancer patients in Scotland, but it is under review by the National Institute for Health and Care Excellence (Nice)."

Oceanflynn (talk) 20:07, 11 December 2016 (UTC)

For urothelial carcinoma NICE provisionally find "When compared with Taxotere and Taxol, the cost of quality-adjusted life years (QALY) would be approximately £76,000 ($100,400) more per QALY gained." says Opdivo Not Recommended for Treating Urothelial Carcinoma in the UK. - Rod57 (talk) 13:55, 31 October 2017 (UTC)

comment
To me it looks like Nivolumab is an immunotherapy that stops cancer from tricking the immune system. The introduction paragraph needs checking ! — Preceding unsigned comment added by AaronNGray (talk • contribs) 16:18, 9 October 2016 (UTC)
 * that's what it says. Jytdog (talk) 18:25, 9 October 2016 (UTC)

Head and neck cancer
Good results in a phase 3 trial (vs chemo) for advanced head and neck cancer. - Rod57 (talk) 12:20, 23 November 2016 (UTC)


 * and Neoadjuvant use before surgery for head & neck cancer is being studied, with encouraging results.  Could mention under Research ? - Rod57 (talk) 22:30, 1 December 2017 (UTC)

FYI FDA modification September 13, 2016
"On September 13, 2016, the U.S. Food and Drug Administration modified the dosage regimen for nivolumab..."

Oceanflynn (talk) 00:07, 25 December 2016 (UTC)

Efficacy - level of detail
User:146.115.177.216 you have added the following in:
 * diff
 * diff
 * diff

Am pinging folks at WP:MED to get further input on this. Please wait for consensus. The refs here are malformed with the embedded URL but that is minor for now.


 * Efficacy

Initial FDA approval for melanoma was based on an unblinded, single-arm study consisting of 120 subjects (i.e., patients). Disease progression was the most common reason for treatment discontinuation (56 subjects). The most common reason for study discontinuation was the patient's death (25 subjects), which in 24 of the 25 cases was due to disease progression. A complete response (defined as "the disappearance of all target lesions" ) was experienced by 4 of the 120 subjects. An additional 34 of the 120 subjects experienced a partial response (defined as "at least a 30% decrease in the sum of diameters of target lesions."). The overall response rate (i.e., sum of complete responses and partial responses) was 38 (31.7%) of 120 subjects, meaning that 68.3% of the subjects did not benefit according to the defined criteria of partial or complete responses. Of the 38 subjects who responded, the average duration of response (duration of response is defined as the time from the complete or partial response until the disease begins to progress again) could not be determined due to the insufficient duration of the study. Data in this paragraph are from the official FDA review of nivolumab.

-- Jytdog (talk) 21:39, 3 March 2017 (UTC)

Dear Jytdog, Thank you for your contribution. Can you clarify why you disapprove of the efficacy content, or how it could be made better? The data are taken directly from the U.S. Food and Drug Administration official review document, which is clearly cited. 146.115.177.216 (talk) 21:45, 3 March 2017 (UTC)


 * Tons of secondary (i.e., more appropriate) sources that support that nivolumab is efficacious in:


 * non-small cell lung cancer – demonstrated meaningful results in terms of efficacy –
 * renal cell carcinoma – objective responses and safety profile of single-agent nivolumab are favorable –
 * solid tumors – multiple high-level evidence has confirmed the efficacy and safety of nivolumab in solid tumors –
 * melanoma – durable responses and improve overall survival in metastatic, refractory melanoma –
 * Boghog (talk) 21:54, 3 March 2017 (UTC)


 * Thanks for talking, IP. and Boghog.  My objection is the level of detail in the proposed content.  We generally don't provide clinical-trial level outcome data.  The "medical use" section generally just describes what a drug is used to treat.   If we are going to actually start to provide efficacy data, this will be a significant change across many articles about interventions (drugs, devices, other therapies, etc).   It is an interesting question.  Jytdog (talk) 22:00, 3 March 2017 (UTC)
 * I agree that the material is too detailed, but the statement that the drug is efficacious can be backed up by reliable secondary sources. That the drug has been approved for use implies that it is efficacious, but it is a good question whether we should explicitly state that. Boghog (talk) 22:06, 3 March 2017 (UTC)
 * I would have thought that the only thing worthy of comment about the FDA approval was that it was based on a single study. Frankly I'd have cut that down to the single sentence "Initial FDA approval for melanoma was based on an unblinded, single-arm study consisting of 120 subjects." along with an appropriate source to support that. That sentence doesn't need a MEDRS-source to support it as it's a simple fact that isn't going to change or be challenged - almost any source would do. Perhaps the study report itself is worth adding as interested readers could then read the details, but the details themselves are not what I'd expect in one of our articles. By all means flesh out the section on effectiveness with good secondary sources that speak to its efficacy, but an encyclopedia isn't a scholarly journal where we would expect the detail on drop-outs, partial responses, etc. from a study. --RexxS (talk) 22:24, 3 March 2017 (UTC)
 * Rexx's summary is much more appropriate. The prior was excessive detail IMO. Doc James  (talk · contribs · email) 00:19, 4 March 2017 (UTC)
 * Agree. This is an encyclopedia and we are meant to be providing summary knowledge. If readers want finer detail ... well, we cite a source they can read. Alexbrn (talk) 01:05, 4 March 2017 (UTC)
 * agree, as well--Ozzie10aaaa (talk) 02:35, 4 March 2017 (UTC)