Timothée Olivier, Medical Oncologist at HUG – Geneva University Hospitals shared a thread on X:

“Out in The Lancet Oncology!

Led by Sruthi Ranganathan with Vinay Prasad, we reviewed the regulatory failure of sotorasib in lung!
-points we made right after ESMO22
-the FDA sensitivity analyses
-our additionnal concerns about OS
-future measures

Check the Reviewed paper here.

Future measures to avoid such failure?

1. double-blind (decreased risk of informative censoring)
2. Overall Survival instead of Progression Free Survival (at least) in poor prognosis settings
3. real-time Blinded Independent Centrak Review (BICR) (quick detection of any not equal to with investigators)
4. long-term survival Follow Up of censored patients
5. real data-sharing

Check out the full paper here.

The story is still ongoing…FDA Oncology, EU Medicine Agency News, Swissmedic.

Thanks for following our works VK Prasad Lab.”

Source: Timothée Olivier/X