Will the FDA approve Merck & Co.'s sac-TMT for treatment of adult endometrial cancer after platinum chemo and PD-1/PD-L1 inhibitor by June 29, 2027?
deadline 2027-06-29
confidence high
tier 2 evidence
85%Asturna estimate
Resolution criterion
Yes if the FDA approves sac-TMT for the indication stated above (Drugs@FDA entry, FDA announcement or Merck & Co. press release) no later than June 29, 2027. A complete response letter, an extension of the PDUFA date or the absence of a decision by then counts as no. An accelerated or conditional approval counts as an approval; a later label update does not change the outcome.
Verified starting state
As of November 2, 2026: according to the Merck & Co. filing of October 29, 2026, the FDA has set a PDUFA target action date of June 15, 2027. Source: https://www.sec.gov/Archives/edgar/data/310158/000110465926119825/tm2628203d1_ex99-1.htm
What pushes it up
- FDA accepted the BLA and granted Priority Review with a PDUFA target action date of June 15, 2027, prior to the June 29, 2027 deadline [tier 1].
- Global Phase 3 trial met primary endpoints of progression-free survival (PFS) and overall survival (OS) with positive data presented at ESMO [tier 2].
What pushes it down
- The PDUFA date of June 15, 2027 is only two weeks before the June 29, 2027 deadline; a standard 3-month PDUFA extension triggered by a major amendment would push approval past the cutoff [tier 1].
- Risk of a Complete Response Letter (CRL) or requests for additional safety data on this novel antibody-drug conjugate [tier 2].
What would move this number most
Whether Merck submits any late major amendments to the BLA that trigger a 3-month PDUFA extension beyond June 29, 2027.
How this number is built
| Deadline | 2027-06-29 |
| Base rate | 87% |
| Best evidence | tier 2 · 3 article(s) used |
| Independent runs | 84 · 86 (spread 2 pts) |
| Confidence | high |
| Evidence cap | not triggered |
| Last revised | 2026-11-02 11:14 |
| Model | gemini-3.6-flash |
Sources consulted