RE:RE:Upcoming CR % @90 days = 71%? Extrapolation on 100 patients Given a high efficacy and safety after only 2 treatments it should be easy to argue to have patients the opportunity to get a 3rd treatment in real life if not CR after 1st 2 treatments. Could the FDA could suggest a 3 rd treatment if one is still not CR at the 9 months mark? IMHO.
CancerSlayer wrote:
Nice post SF....the FDA will be looking at more than just the CR rate. In their 2018 guidance, the FDA specifically stated that a treatment's real-world effectiveness/progression-free disease (& not just a response rate/efficacy) will play a role in providing supportive evidence for an approval. I also believe the FDA will not only be focusing on clinical/efficacy value of a new treatment, but also its economic/efficiency value, which our ACT is leading the pack with its recommended two-dose only regimen. Furthermore, the new commissioner of the FDA (Dr. Robert Califf) also appears to champion not only more innovative strategies, but also getting promising new drugs to patients sooner via use of the AA pathway. This FDA approval landscape (priorities) has likely changed significantly due to the pandemic. And it is not uncommon for newly approved drugs to actually underperform existing therapies in terms of treatment response rates, indicating the increased reliance on other performance metrics & need for more options.
In the wake of Keytruda's approval (for what some would consider a lackluster performance) & considering all of the above, we are in an excellent position to succeed. All imo...good luck.