Theraspheres and FDA approval

So, BTG (now owned by Boston Scientific) have just received full FDA approval for Theraspheres (the old competitor to Sirtex Sirspheres)

The interesting thing for me is that the approval is based on a single arm study (TARGET) of just over 200 patients. It appears to have started about 2 years ago.

I'm posting a few links and ask you to double check:

https://clinicaltrials.gov/ct2/show/NCT03295006

https://www.bostonscientific.com/en-US/medical-specialties/interventional-radiology/interventional-oncology/cancer-therapies-ablation/therasphere/proven-results/target-study.html

https://www.fiercebiotech.com/medtech/boston-scientific-s-recently-approved-radioactive-microspheres-extend-liver-cancer-survival

I guess it raises the possibility that an RCT might not be required for Oncosil.

It also continues a theme of general endorsement for internal radiation therapies in general.

I think this is very positive, and I am looking forward to the FDA's view.

I have changed my sentiment from hold to buy.