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Registered forecast

55% registered probability event by 2027-03-31 Unresolved

FDA approves first-line sunvozertinib in EGFR exon 20 insertion NSCLC on or before 2027-03-31

FF-003 Registered Unresolved
Registered probability
55%
Decision by
2027-03-31
Reading window
2026-09-23 → 2027-07-31
Decision stage
  1. 5 Guideline
  2. 6 Regulatory
  3. 7 Coverage
Baselines it has to beat
  • Authority base rate 60%
  • Calendar cycle 40%
  • Analyst proxy 65%

nextconsensus.com/forecast/ff-003/ registry snapshot 2026-11-07 Share image

NextConsensus registered this probability on 2026-09-22. It is one of 65 registered forecasts.

The proposition

What was registered

The FDA approves a first-line / initial-treatment indication for sunvozertinib (ZEGFROVY) in EGFR exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer — expected as an efficacy supplement to NDA 219839, held by Dizal at the cutoff — with an approval action dated on or before 2027-03-31. The resolution window closes 2027-07-31 so that this record is read at the same sitting as FF-002's; an approval action dated 2027-04-01 or later resolves this proposition NO.
Who decides
US Food and Drug Administration (FDA), Center for Drug Evaluation and Research, Office of Oncologic Diseases (US)
Decision stageThe kind of body that has to act: a guideline panel, a regulator, or a payer. 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.
Decision typeThe type of decision this forecast is counted with, such as FDA actions by their goal dates
FDA label revision
Scope
EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC

The estimate

The number and the baselines it has to beat

55% probability, method v0.1.0 · frozen at the 2026-09-22 cutoff

The estimate that the named body takes the action by the deadline, from what was public at the cutoff.

The alternatives it was registered against, each with the reasoning that produced it. They were set at registration: how often this kind of decision happens on time, what the calendar alone suggests, and a reading of the same public record without this method. Each one's reasoning shows whether it is a count of past decisions or an estimate.

Authority base rate 60%

Reference class: FDA efficacy supplements adding a line of therapy to an approved oncology drug, supported by a randomized phase 3 that met its primary endpoint and carrying Breakthrough Therapy Designation, acted on within eight and a half months of submission (2026-07-14 to 2027-03-31 here). To my understanding most such supplements receive priority review and are approved at or before the goal date, and a minority run on the standard clock or take an extension; that shape gives roughly 0.6. ESTIMATE FROM PRECEDENT, NOT AN ENUMERATED COUNT — the enumerated corpus for rung 6 is the object of the proof cycle and, per the repo's own fda-label-v1-invalidation review under workspace/reviews/ (a review of this repo's backtest, not a source fact), the one that existed was not usable. Recorded as the honest state of this baseline at the cutoff.

Calendar cycle 40%

A model that knows only clocks and nothing about the evidence, with its rule stated: receipt on or before 2026-07-14 (SRC-004); review designation unknown, so priority and standard each 0.5; goal 6 or 10 months from receipt, so on or before 2027-01-14 (inside the deadline) or 2027-05-14 (outside it); approval at the first goal date with prior 0.85 (first-cycle approval of a filed efficacy supplement — a prior, not a count); under priority, a major-amendment extension that carries the action past the deadline with prior 0.15; under standard, an action at least six weeks early with prior 0.1. 0.5 x 0.85 x 0.85 + 0.5 x 0.85 x 0.1 = 0.40. Every input except the receipt bound is a prior and is labelled as one.

Analyst proxy 65%

A regulatory or thoracic-oncology analyst reading the same public record on 2026-09-05 — Breakthrough Therapy Designation in the setting, the original NDA reviewed under priority, an NEJM-published positive phase 3, a supplement accepted by 2026-09-01, and a $600m upfront licence completed the same day — would most likely assume priority review, pencil a goal date in the first quarter of 2027, and discount for the absence of any announced designation or goal date and for the crossover-confounded survival data. Reconstructed as about 0.65; estimated by reconstructing that read, not by surveying analysts. The draft's own number sits below it because the draft gives more weight to the silence about the designation.

Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved.

The method and every record are public, so you can check the work.

The clock

Dates that constrain the record

Evidence as of
2026-09-22
Nothing after this date informed the estimate.
Registered
2026-09-22
Frozen and hashed.
Reading window
2026-09-23 → 2027-07-31
When the outcome can be read against the rule.
Event by
2027-03-31
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
ledger c1f038e701df6f687ad521494d0f0e5fec7c39b3f565f3e38732de1317ea768a · operator record jc-1790109835059-8d38c270

Around this record

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Resolution

The rule that settles the forecast

Resolves YES if the openFDA Drugs@FDA record for application number NDA219839 — queried as https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA219839%22 , by application number and not brand name, so that a rebrand after the AstraZeneca licence cannot empty the query — contains a submission with submission_type SUPPL (or, if the supplement literal in the live record differs from SUPPL, any submission whose submission_type is not ORIG), submission_status AP, and submission_status_date on or before 20270331 (the field is YYYYMMDD), whose approved labeling covers the first-line / initial-treatment (previously untreated) setting for EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC. The indication is read from Section 1 (INDICATIONS AND USAGE) of the label PDF linked from that submission's application_docs entry of type Label or, if that link is absent, from the current label on the Drugs@FDA web record for NDA 219839 at https://www.accessdata.fda.gov/scripts/cder/daf/ ; a labeling supplement that adds WU-KONG28 to Section 14 (CLINICAL STUDIES) without changing Section 1 does NOT count. An action dated exactly 2027-03-31 counts. The date read is submission_status_date; if openFDA has not refreshed by the reading date (meta.last_updated earlier than the approval), the Action Date shown for that supplement on the Drugs@FDA web record governs, and if the two disagree the date on the approval letter (application_docs type Letter) governs. Adjudication floor: read no earlier than 2027-08-31 and no later than 2027-10-31, at the same sitting as FF-002. Resolves NO if no such approval action is dated on or before 2027-03-31 — including the case where the same indication is approved between 2027-04-01 and 2027-07-31, which resolves FF-002 YES and this record NO, by design. Resolves VOID, with the reason recorded, only if FDA restructures Drugs@FDA or withdraws the openFDA drugsfda endpoint so that no per-supplement action date can be read from either the JSON or the Drugs@FDA web record; while either source publishes the date, the rule stands. If the sponsor withdraws the supplement, or receives a complete response and does not obtain an approval by 2027-03-31, the record resolves NO on plain terms, not VOID. A change of application holder from Dizal to AstraZeneca, or of brand name, has no effect: the rule matches on application number NDA219839 and the query is by application number. Exclusions carried unchanged from FF-002: a supplement approved only for a later-line, maintenance or non-NSCLC indication does NOT count; conversion of the existing accelerated approval in the previously treated setting to traditional approval does NOT count; a first-line indication restricted to a narrower population than the full exon 20 insertion group (for example nonsquamous histology only) DOES count, provided it is first-line. A first-line indication approved under a new NDA rather than a supplement to 219839 DOES count, provided the labeling covers the specified population and setting; the adjudicator then reads that NDA's ORIG submission by the same fields. Both sources are public and unauthenticated; the JSON is machine-readable, the label is a PDF read by a person; no oncology judgement is needed. An approval action dated on or before the availability cutoff means the proposition was resolved before it was frozen: VOID as ill-posed, not YES.

Source the rule names: openFDA Drugs@FDA record for NDA 219839, with the Drugs@FDA web record and the approval letter as fallbacks for the action date

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 label revision): 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
55% 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 2026-09-22.

review pathway
Two Breakthrough Therapy Designations are in the archive: one for the first-line setting, reported only by sponsor releases (SRC-002 and SRC-004: 'in this setting'; SRC-006: 'for this treatment-naive patient population'), and an earlier one in the platinum-pretreated setting reported in April 2024 (SRC-008, secondary). The original NDA 219839 was reviewed under PRIORITY (SRC-001, ORIG-1, AP 20250702). The review designation of the first-line supplement — priority or standard — is in no archived file; the 2026-09-01 release says only 'accepted'. This is the hinge of the proposition; see mechanism.
submission type
supplemental New Drug Application (efficacy supplement adding a new line of therapy to an approved molecule), per sponsor releases only: 'has been submitted' (SRC-004, 2026-07-14) and 'has been accepted' (SRC-002, 2026-09-01). openFDA shows no supplement row of any kind as of its 2026-09-02 refresh (SRC-001).
evidence class
randomized, open-label, multinational phase 3 (WU-KONG28, NCT05668988) versus carboplatin-pemetrexed: 'phase 3, international' per the NEJM abstract (SRC-003); 'open-label' per the sponsor release (SRC-005) and The ASCO Post (SRC-007); enrolled December 2022 to May 2025 (SRC-007); 15 countries per SRC-005 and 16 per SRC-006; presented as ASCO late-breaking abstract LBA8500 and published in NEJM on 2026-05-29 (SRC-003, SRC-005).
pivotal n
324 randomized 1:1 (163 sunvozertinib, 161 chemotherapy) per the NEJM abstract (SRC-003)
endpoint type
primary: progression-free survival by blinded independent central review, 10.3 vs 7.5 months, HR 0.65 (95% CI 0.50 to 0.85), P<0.001 (SRC-003; the sponsor release gives P=0.0008, SRC-005); 12-month PFS 46.1% vs 26.7%; objective response 58.9% vs 31.1%; overall survival immature at 38.9% maturity (SRC-003) with 101 of 112 (90.2%) chemotherapy patients crossed over (SRC-007); grade 3 or higher adverse events 75.5% vs 56.7% (SRC-003); serious adverse events 45.4% vs 26.7% (SRC-007). Data cutoff read as 2026-01-16 from 'As of January 16, 2026, 324 patients were randomized' (SRC-005), which the release states as a randomization-count date; the NEJM abstract gives no cutoff date.
approved competitors in class
No archived file names an approved first-line regimen for this population. What the archive supports: the sponsor's statement that 'no oral targeted therapies have been approved for the first-line treatment of EGFR exon20ins NSCLC' and that first-line treatment 'largely relies on chemotherapy-based regimens' (SRC-006, 2026-05-27). FF-001 and FF-002 record one approved first-line regimen, amivantamab with carboplatin/pemetrexed, from secondary reporting archived nowhere in this repo; if that record is right, priority review is less automatic than the sponsor's framing suggests, because WU-KONG28's control arm was carboplatin-pemetrexed alone (SRC-003). Load-bearing for the designation question and unresolved by the archive; the founder should archive the Rybrevant Drugs@FDA record before any public evidence story leans on it.
months since last guideline revision
not applicable — the forecast object is an FDA approval action on a PDUFA clock, not a guideline revision. For the record, the sponsor cites NCCN NSCLC Version 6.2026, accessed July 2026, in both the 2026-07-14 and the 2026-09-01 release (SRC-004, SRC-002).
panel cycle position
not applicable for the same reason. No ODAC meeting is mentioned in any archived file; the FDA advisory-committee calendar itself is not archived, so this is an absence claim.
sponsor request status
supplemental NDA submitted to FDA on or before 2026-07-14 (SRC-004: 'has been submitted') and accepted on or before 2026-09-01 (SRC-002: 'has been accepted by the US Food and Drug Administration (FDA)'). Receipt date, filing date, review designation and goal date are all undisclosed. Press release only: openFDA lists approved actions and cannot corroborate a pending submission (SRC-001).
odac referral
none announced in any archived file as of the availability cutoff; the advisory-committee calendar is not archived (absence claim)
sponsor state change
AstraZeneca entered an exclusive global licence with Dizal on 2026-07-14 ($600m upfront, up to $900m in milestones, tiered royalties; SRC-004) and announced its completion on 2026-09-01, four days before this cutoff, with a US launch of the second-line indication planned for the fourth quarter of 2026 (SRC-002). The application holder of record in openFDA is still DIZAL as of the 2026-09-02 refresh (SRC-001).

Sources

Everything the estimate was built from

Each was retrieved on or before the 2026-09-22 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.

  1. SRC-001 openFDA Drugs@FDA record for application NDA219839 (ZEGFROVY, sponsor DIZAL), meta.last_updated 2026-09-02. Establishes the starting state this proposition is measured against: exactly one submission, ORIG-1, submission_status AP dated 20250702, review_priority PRIORITY, submission_class TYPE 1 (New Molecular Entity); no supplement of any kind is present, so no first-line indication is approved at the cutoff. Also the resolution source; this copy was queried by brand name, the resolution rule queries by application_number. Bytes retrieved from the network 2026-09-04 for the fda-nsclc-sunvozertinib-first-line-approval draft (its SRC-003) and copied here unchanged on 2026-09-05, so the starting state is read one day before this draft's cutoff — see contingency_notes.

    https://api.fda.gov/drug/drugsfda.json?search=products.brand_name:%22ZEGFROVY%22&limit=5

    Retrieved 2026-09-05 · sha256 9dc982bddee2169e1df1b7fdbb7182de826569802f9601ed15b434dd5a4f2b05

  2. SRC-002 AstraZeneca press release dated 2026-09-01 (BUSINESS WIRE, BioSpace carriage) announcing completion of the global licence from Dizal. Load-bearing: the only archived statement that the first-line supplemental NDA 'has been accepted by the US Food and Drug Administration (FDA)' and that 'the US FDA and China's CDE both granted Breakthrough Therapy Designation to ZEGFROVY in this setting'. It gives no acceptance date, no filing date, no review designation and no goal date — the word 'priority' does not appear in it. Also records that AstraZeneca will launch the second-line indication in the US in the fourth quarter of 2026, and cites NCCN NSCLC Version 6.2026 (accessed July 2026) for a subsequent-therapy listing. Bytes retrieved 2026-09-04 for the fda-nsclc-sunvozertinib-first-line-approval draft (its SRC-001); copied here unchanged 2026-09-05.

    https://www.biospace.com/press-releases/astrazeneca-completes-global-license-agreement-for-oral-egfr-inhibitor-zegfrovy-sunvozertinib-for-lung-cancer

    Retrieved 2026-09-05 · sha256 779b724b7d2e236b854b931f41c5ed63d59aebe6cbbb481bebe6cf8a49b55332

  3. SRC-003 PubMed E-utilities XML for the NEJM primary publication (PMID 42212913, doi 10.1056/NEJMoa2604461, published online 2026-05-29), 'First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations'. Source for n=324 (163 vs 161), carboplatin-pemetrexed control, PFS 10.3 vs 7.5 months by BICR, HR 0.65 (95% CI 0.50 to 0.85), P<0.001, overall survival immature (38.9% maturity), objective response 58.9% vs 31.1%, grade 3 or higher adverse events 75.5% vs 56.7%, and the accelerated-approval status of the later-line indication. Archived via PubMed because nejm.org serves a bot-challenge page. Bytes retrieved 2026-09-04 for the fda-nsclc-sunvozertinib-first-line-approval draft (its SRC-002); copied here unchanged 2026-09-05.

    https://eutils.ncbi.nlm.nih.gov/entrez/eutils/efetch.fcgi?db=pubmed&id=42212913&retmode=xml

    Retrieved 2026-09-05 · sha256 fdf43f48643ab11e991f9b089d2bce0f45675bf6a15f20be067355715688809e

  4. SRC-004 AstraZeneca press release dated 2026-07-14 announcing the exclusive global licence agreement with Dizal. Load-bearing for the review clock: it states that a supplemental NDA for the first-line setting 'has been submitted to the US Food and Drug Administration (FDA)', which fixes FDA receipt on or before 2026-07-14 — the earliest archived upper bound on the clock start — and that FDA granted Breakthrough Therapy Designation in this setting. Footnote 1 cites NCCN NSCLC Version 6.2026, accessed July 2026, for a Category 2A subsequent-therapy listing. Bytes retrieved 2026-07-31 for the registered nccn-nsclc-sunvozertinib-first-line draft (FF-001, its SRC-003); copied here unchanged 2026-09-05 — a copy retrieved before the cutoff is available at the cutoff.

    https://www.astrazeneca.com/media-centre/press-releases/2026/astrazeneca-licenses-novel-egfr-inhibitor.html

    Retrieved 2026-09-05 · sha256 56e8ee9aceb9ca38a075dc5b969135c71e2b48cc9f82487f39a0c49d35697f0f

  5. SRC-005 Dizal press release dated 2026-05-29 announcing the WU-KONG28 results. Source for 'As of January 16, 2026, 324 patients were randomized in a 1:1 ratio', the byte from which the 2026-01-16 date in covariates.endpoint_type and clocks.t_evidence is read (as FF-002 read it, as the data cutoff and t_evidence), P=0.0008, the 'open-label' design, enrolment across 15 countries, and — load-bearing for this proposition by contrast — that China's NMPA 'accepted and granted Priority Review designation' to the first-line NDA, a form of words no archived file uses for the US supplement. Bytes retrieved 2026-07-31 for FF-001 (its SRC-001); copied here unchanged 2026-09-05.

    https://www.prnewswire.com/news-releases/dizal-announces-phase-3-wu-kong28-results-zegfrovy-sunvozertinib-outperforms-platinum-doublet-chemotherapy-in-first-line-egfr-exon-20-insertion-mutation-positive-non-small-cell-lung-cancer-302785656.html

    Retrieved 2026-09-05 · sha256 8d36a5ba14efa04cbdbbc0ea3ceda931828048f5dfdeed0c9621ed5fdd394489

  6. SRC-006 Dizal press release dated 2026-05-27 announcing China NMPA acceptance with priority review of the first-line NDA. Source for the statement that ZEGFROVY 'has received Breakthrough Therapy Designations (BTDs) from both the U.S. FDA and China's CDE for this treatment-naive patient population' and that 'globally, no oral targeted therapies have been approved for the first-line treatment of EGFR exon20ins NSCLC' — the sponsor's framing of available therapy, which is what a priority-review determination turns on. Says 16 countries where the 2026-05-29 release says 15. Bytes retrieved 2026-07-31 for FF-001 (its SRC-004); copied here unchanged 2026-09-05.

    https://www.prnewswire.com/news-releases/dizals-zegfrovy-sunvozertinib-new-drug-application-accepted-and-granted-priority-review-by-china-national-medical-products-administration-for-first-line-treatment-of-egfr-exon-20-insertion-mutated-non-small-cell-lung-cancer-302783017.html

    Retrieved 2026-09-05 · sha256 6dc5663822dd9950c749c765045abe4c3ce4d8f6f632251106d222c577549214

  7. SRC-007 The ASCO Post report (posted 2026-06-08) on the WU-KONG28 NEJM paper. Independent secondary reporting; source for enrolment between December 2022 and May 2025, median follow-up 24.0 vs 18.0 months, crossover of 101 of 112 (90.2%) chemotherapy patients, serious adverse events in 45.4% vs 26.7%, and one treatment-related death in the chemotherapy group. These are the facts a complete response or a major amendment would most plausibly rest on. Bytes retrieved 2026-07-31 for FF-001 (its SRC-005); copied here unchanged 2026-09-05.

    https://ascopost.com/news/june-2026/sunvozertinib-in-nsclc-with-egfr-exon-20-insertion-mutations/

    Retrieved 2026-09-05 · sha256 81a89a602bfbc251e80c5cf06192df596808daa1d552db12ff7475987b5dda2b

One more archived source, a secondary summary the record does not rely on, is held in the ledger and not listed here.

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