Will the FDA approve ivonescimab in combination with chemotherapy in EGFR-mutated NSCLC after failure of a tyrosine kinase inhibitor?
deadline 2026-11-30
confidence medium
tier 2 evidence
52%PolySignal estimate
Resolution criterion
Yes if the FDA publishes an approval (Drugs@FDA or a Summit Therapeutics release) no later than 30 November 2026. A complete response letter, a postponement of the PDUFA date, or the absence of a decision count as no. A label restricted to a subgroup that does not cover this combination and population (e.g. non-squamous histology only) counts as no; flag for manual review if the approved label's exact scope is unclear.
Verified starting state
BLA accepted, PDUFA date 14 November 2026. The interim progression-free survival analysis of HARMONi-3 (squamous cohort) did not meet its pre-specified significance threshold. Updated overall survival from HARMONi showed an HR of 0.76 in Western patients, not statistically significant. (July 2026)
What pushes it up
- The FDA accepted the BLA with an active PDUFA target action date of 14 November 2026, within the resolution window [tier 1].
- Updated overall survival data from HARMONi shows a positive directional trend with an HR of 0.76 in Western patients [tier 1, tier 2 - article 0].
What pushes it down
- Updated overall survival HR of 0.76 in Western patients was not statistically significant, raising potential FDA scrutiny regarding applicability to US/Western populations [tier 1, tier 2 - article 0].
- The interim progression-free survival analysis of the HARMONi-3 squamous cohort failed to reach its pre-specified statistical significance threshold [tier 1].
- Any 3-month PDUFA extension or Complete Response Letter (CRL) would push the decision past the 30 November 2026 deadline, resolving the question as No [tier 1].
What would move this number most
Whether the FDA considers the Western subgroup data and overall benefit-risk profile sufficient without requiring statistically significant Western OS data.
How this number is built
| Deadline | 2026-11-30 |
| Base rate | 73% |
| Best evidence | tier 2 · 2 article(s) used |
| Independent runs | 38 · 52 · 54 (spread 16 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-09-22 22:15 |
| Model | gemini-3.7-flash |
Sources consulted
Probability history
2026-09-22 22:15 52% 6 article(s) on file · gemini-3.7-flash
Reasons not recorded for this revision (detailed history has only been kept since recently).
2026-09-21 23:10 70% 6 article(s) on file · openai/gpt-oss-120b (Groq)
Reasons not recorded for this revision (detailed history has only been kept since recently).
2026-09-21 22:17 44% 6 article(s) on file · gemini-3.5-flash
Reasons not recorded for this revision (detailed history has only been kept since recently).
2026-09-21 22:13 55% 6 article(s) on file · gemini-3.7-flash
Reasons not recorded for this revision (detailed history has only been kept since recently).
2026-09-19 07:32 70% 5 article(s) on file · gemini-3-flash-preview
Reasons not recorded for this revision (detailed history has only been kept since recently).