Initiate the withdrawal of the accelerated approval indication for KEYTRUDA for gastric cancer
Delivered by the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 29 Jul 2021
- Due
- 31 Jan 2022
- Delivered
- by 1 Jan 2022
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“As agreed with the FDA, Merck will initiate the withdrawal in Jan. 2022.”
What we found
Evidence strength A What the grades mean
Merck confirmed in its 2022 10-K filing that it initiated the withdrawal of the U.S. accelerated approval indication for Keytruda for gastric cancer during 2022.
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A Merck & Co., Inc. 10-K filed 2022-02-25
“In 2022, Merck initiated the withdrawal of the U.S. accelerated approval indication for Keytruda for the treatment of patients with recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma” ✓ confirmed on the page
Market reaction: the shares moved +3.5% against the S&P 500 over the three sessions around the disclosure (24 Feb 2022 to 1 Mar 2022). What this measures
Checked 2 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory other
- Indicative materiality
- Medium rules
- Action
- Initiate
- Deliverable
- Withdrawal of KEYTRUDA accelerated approval indication
- Language
- Firm (“will”, “on track to”)
- In the company’s control
- High
- Specificity
- High
- Conditional
- Yes: As agreed with the FDA
- Depends on
- Regulatory
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: disagreesClaude (Anthropic) re-read the evidence blind and read it as “no_evidence”.
- Tie-breakA stronger model read the evidence and both earlier answers, without knowing which was recorded, and agrees with the second check.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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Report an error in this entry Reference: KI-C-2021-MRK-004207 · Corrections policy