Registered forecast
15% registered probability event by 2026-11-14 Unresolved
FDA approves ivonescimab for EGFR-mutated non-small cell lung cancer after EGFR TKI therapy on or before the disclosed PDUFA goal date of 2026-11-14
FF-011 Registered - Registered probability
- 15%
- Event by
- 2026-11-14
- Resolution window
- 2026-09-27 → 2026-11-14
- Target rung
- 5 Guideline
- 6 Regulatory
- 7 Coverage
- Baselines it has to beat
-
- Authority base rate 70%
- Calendar cycle 65%
- Analyst proxy 25%
nextconsensus.com/forecast/ff-011/ registry snapshot 2026-10-06 Share image
NextConsensus registered this probability on 2026-09-26. It is one of 14 registered FDA goal-date forecasts.
The proposition
What was claimed
The FDA takes an approval action on a Biologics License Application for ivonescimab (applicant Summit Therapeutics) for EGFR-mutated non-small cell lung cancer previously treated with an EGFR tyrosine kinase inhibitor, with an approval action date on or before 2026-11-14, the PDUFA goal action date disclosed in Summit Therapeutics' Form 8-K filed 2026-09-15.
- Authority
- US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US)
- Target rungA step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung
- Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc.
- Forecast classThe group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates
- FDA action by goal date
- Scope
- EGFR-mutated non-small cell lung cancer after EGFR TKI therapy
The estimate
The number and the baselines it has to beat
The alternatives it was registered against, each with the reasoning that produced it.
ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. First-cycle approval of original BLAs at the disclosed goal date, across review types. No enumerated count exists in this repository yet.
A clock-only model: the goal date is inside the window and FDA meets most goal dates, discounted for the lower first-cycle approval share of standard-review original applications. With no evidence input it cannot see the OS result.
An analyst reading the same public record on 2026-09-24 would weigh FDA's stated need for a statistically significant OS benefit and a primary OS analysis that missed it against a strong PFS result, later OS analyses pointing the same way, a positive OS trial in China and a sponsor still working toward approval. Such an analyst would call a complete response the likely outcome, with a real minority chance of approval. Estimated by reconstructing that read, not by surveying analysts.
Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved.
The clock
Dates that constrain the record
- Evidence cutoff
- 2026-09-26
Nothing after this date informed the estimate. - Registered
- 2026-09-26
Frozen and hashed. - Resolution window
- 2026-09-27 → 2026-11-14
When the adjudicator can read the outcome. - Event by
- 2026-11-14
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
8a2d166c0ea14aa76d0a28312995a97f845fb8289237dadc0a520404c5c5de3c · operator record jc-1790461082276-da68aed0
Around this record
- This kind of deadline
- Check it, follow it
Single-claim evaluation
Waiting on the FDA for an asset of your own?
Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page.
Resolution
The rule that settles the forecast
Resolves YES if the openFDA Drugs@FDA record returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22ivonescimab%22 contains an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-14, and the Drugs@FDA approval letter or label for that application names in its indication EGFR-mutated (EGFR mutation-positive) non-small cell lung cancer that was previously treated with, or progressed on or after, an EGFR tyrosine kinase inhibitor. An approval for a narrower population than the applicant sought (for example non-squamous disease only, or only after a third-generation EGFR tyrosine kinase inhibitor) still resolves YES, as does an approval under accelerated approval. Resolves NO if no approval action is dated on or before 2026-11-14: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-14 resolves NO as occurred_after_deadline. 2026-11-14 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-11-28. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name ivonescimab) governs, and if neither lists the product, FDA's Purple Book (https://purplebooksearch.fda.gov/, searched by ivonescimab) governs for the licensure date, with the approval letter for the indication. The application number was not public at the cutoff, so the rule reads by name; a four-letter suffix on the nonproprietary name (ivonescimab-xxxx) or a proprietary name does not change the identification. At the cutoff ivonescimab was not approved in the United States (SRC-001). Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands.
Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22ivonescimab%22, https://www.accessdata.fda.gov/scripts/cder/daf/, https://purplebooksearch.fda.gov/
Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far.
What this record will show once it resolves
Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate.
- The finding
- As the rule above reads it: occurred on time, did not occur, or left unscored.
- The readers and their sources
- Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus.
- The number against its baselines
- 15% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them.
Reasoning
What the number rests on
The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers.
Frozen covariatesThe facts about the evidence and the authority's process that were frozen with the forecast at its cutoff
The state of the record at the cutoff
Recorded as they stood on 2026-09-26.
- review pathway
- not stated in the archived sources; about twelve months from a fourth-quarter 2025 submission to the goal date is consistent with standard review (drafter's understanding, unverified)
- submission type
- original BLA; PD-1 and VEGF bispecific antibody not approved in the United States (SRC-001)
- evidence class
- one multiregional, double-blind, placebo-controlled phase 3 trial, HARMONi (SRC-001, SRC-002); supporting single-region phase 3 trial in China, HARMONi-A, which also enrolled HARMONi's patients from China (SRC-002)
- pivotal n
- 219 per arm in the intention-to-treat population; 83 and 82 western patients (SRC-001)
- endpoint type
- dual primary endpoints: PFS, met (SRC-001); OS, primary analysis not statistically significant (HR 0.79, p=0.057, SRC-001)
- approved competitors in class
- no FDA-approved regimen in this setting has shown a statistically significant OS benefit, as Summit states (SRC-002); the approved options are not named in the archive
- months since last guideline revision
- not applicable — no guideline is the subject of this proposition
- panel cycle position
- not applicable — the act is an FDA approval action
- sponsor request status
- BLA submitted in the fourth quarter of 2025 and accepted for filing in January 2026; FDA noted that a statistically significant OS benefit is necessary in this setting (SRC-002)
- odac referral
- none announced in the archived sources
- sponsor state change
- June 2026 OS analysis made available to FDA (SRC-002); updated OS presented at WCLC 2026 on 2026-09-15 (SRC-001)
Sources
Everything the estimate was built from
Each was retrieved on or before the 2026-09-26 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible.
-
SRC-001Summit Therapeutics press release filed as Exhibit 99.1 to its 8-K of 2026-09-15 (the text layer under the slide images of the exhibit). States that Summit's BLA, based on the phase 3 HARMONi trial of ivonescimab plus chemotherapy in EGFR-mutated non-squamous NSCLC after a third-generation EGFR TKI, was accepted for filing in January 2026 with a PDUFA goal action date of November 14, 2026; that the primary OS analysis (April 2025) gave HR 0.79 (95% CI 0.62-1.01; p=0.057), not statistically significant; that later analyses with June 2026 data gave HR 0.76 (nominal p=0.0151); and that ivonescimab is not approved by any regulatory authority in Summit's territories, including the United States. -
SRC-002Summit Therapeutics 10-Q for the quarter ended 2026-06-30, filed 2026-07-23. States that Summit submitted the BLA in the fourth quarter of 2025, that FDA accepted it for filing in January 2026 with a PDUFA goal action date of November 14, 2026, and that FDA noted a statistically significant OS benefit is necessary to support marketing authorization in this setting and the PFS results may not be sufficient. Also states that the June 2026 OS results were made available to FDA.