Photo of Timothée Olivier taken from ResearchGate.net
Oct 10, 2023, 00:40
Timothée Olivier: Wow, a long awaited decision about the CodeBreaK 200 trial… with a PFS per BICR considered… unreliable!
Timothée Olivier, Clinic Director at HUG – Geneva University Hospitals, shared the following post by FDA Oncology, adding the following:
“Wow, a long awaited decision about the CodeBreaK 200 trial… with a PFS per BICR considered… unreliable!
We pointed many limitations, including this, right after the 2022 ESMO presentation more than 1 year ago…”
Quoting FDA Oncology’s post:
“FDA Oncologic Drugs Advisory Committee voted 10-2 against the question: Can the primary endpoint, PFS per blinded independent central review, be reliably interpreted in CodeBreaK200? Re: sotorasib for KRAS G12C mutated advanced/metastatic NSCLC.”
Source: Timothée Olivier/Twitter and FDA Oncology/Twitter
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