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08/19/17 6:27 PM

#130647 RE: ELecsol28 #130627

A quick note...

Take a look at this list of upcoming NICE appraisal guidances in alphabetical order.
https://www.nice.org.uk/guidance/indevelopment?type=hst,ta

You'll probably note that many of the drugs show a TBC (to be confirmed) date for their publication.

Below are a list of a few listed with late 2018 publication dates, or 2019 publication dates.

You will note they have all already been approved by the FDA.

It's not often that a drug that has not been approved to make it on to this list with a set appraisal date. You can see from below that Durvalumab for NSCLC is another one that has not received approval (like DCVax-L) that has a STA in progress and a publication date.


Blinatumomab's publication date is set for February 28, 2019.

It was granted FDA approval on July 11, 2017.
https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm566708.htm



Durvalumab (Astra Zeneca's checkpoint inhibitor) has a publication date of January 23, 2019.

On July 31, 2017, the FDA granted Breakthrough Therapy designation for Durvalumab for non-small cell lung cancer - the same indication with the publication date of January 23, 2019. Durvalumab has already received FDA accelerated approval for bladder cancer on May 1, 2017.



Crizotinib's publication date is May 30, 2018.

It was granted FDA approval on March 11, 2016.
https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm490391.htm



Cerliponase alfa's publication date is June 27, 2018.

It was granted FDA approval on April 27, 2017.
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm555613.htm



Dabrafenib's publication date is set for December 26, 2018.

It was granted FDA approval on June 22, 2017.
https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm564331.htm



Betrixaban's publication date is set for September 26, 3018.

It was granted FDA approval on June 23, 2017.
https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm564422.htm



And these are just a few of those on the list. I only got to the D's.

And you can see that almost all of these drugs are already FDA approved, and they are all scheduled for publication in 2018 and 2019... some a full year or more after FDA approval.

So maybe we could just relax and be grateful DCVax-L actually has an appraisal date as well as a publication date when they aren't even FDA approved yet.



This was an older post I did on this same subject back in February 2017, for those who are interested.