NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Thanks for your comments.

In fact, there have been oncology drugs approved having ECAs as the article that you cited noted. Furthermore, new draft guidance representing a renewed stance on ECAs has already been published.

Murcidencel has been studied in three trials and only one of those trials had an ECA, but if you want to know about ECA approvals:

As of 2019, 45 drugs had been approved supported by ECAs as their only controls—that is significant going back 20 yrs in history—only about 40 drugs are approved each year roughly if I recall correctly. There may have been more approvals between 2019 and 2022, but I haven’t checked.

In terms of cancer drugs specifically that were approved having ECAs as their only controls: Erdafitinib, Selumetinib, Blinatumomab, Keytruda+lenvatinib combo, and several combos for renal cancer … and others that I am sure I have forgotten.

I recommend researching ECA approvals further for yourself. Include RAs abroad and the evolving stance of the FDA toward RWE in your search.



https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8332598/

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847