FDA approves neladalkib for ALK-positive non-small cell lung cancer after a prior ALK inhibitor on or before the disclosed PDUFA goal date of 2026-11-27

The proposition

What was claimed

The FDA takes an approval action on Nuvalent's (a GSK company since July 2026) New Drug Application for neladalkib (NVL-655) for the treatment of tyrosine kinase inhibitor pre-treated advanced ALK-positive non-small cell lung cancer, with an approval action date on or before 2026-11-27, the target decision date disclosed in GSK's Form 6-K furnished 2026-07-22, and stated as the PDUFA date in Royalty Pharma's filing of 2026-08-05.

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

ALK-positive NSCLC after a prior ALK inhibitor

The clock

Dates that constrain the record

resolution window

Today

Evidence cutoff2026-10-06 Registered2026-10-06 Window opens2026-10-07 Deadline2026-11-27

Evidence cutoff

2026-10-06

Registered

2026-10-06

Window opens

2026-10-07

Deadline

2026-11-27

Evidence cutoff

2026-10-06
Nothing after this date informed the estimate.

Registered

2026-10-06
Frozen and hashed.

Resolution window

2026-10-07 → 2026-11-27
When the adjudicator can read the outcome.

Event by

2026-11-27
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar

ledger a912641a8f1dfb783320fb6599a0e4d8f2aa1d9250f29ebb3abe316ffc6a68b0 Copy · operator record jc-1791309827796-23e39d52

Resolution

The rule that settles the forecast

Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22neladalkib%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22NELADALKIB%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-27, and the Drugs@FDA approval letter or label for that application names ALK-positive non-small cell lung cancer in its indication. An approval for a narrower population than the applicant sought (for example after a specific prior ALK inhibitor) still resolves YES, as does accelerated rather than traditional approval. Resolves NO if no approval action is dated on or before 2026-11-27: 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 2026-11-27 resolves NO as occurred_after_deadline. Read no earlier than 2026-12-11. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name neladalkib) governs. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. 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:%22neladalkib%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22NELADALKIB%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/

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

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 2026-10-06, including the 3 fields whose values were unknown then. Those are left unknown rather than filled in.

review pathway

priority review (SRC-002); Breakthrough Therapy and Orphan Drug designations (SRC-005)

submission type

original NDA (SRC-002, SRC-004)

evidence class

registration-directed Phase 1/2 trial (ALKOVE-1) in TKI pre-treated patients; no randomized trial in this population cited (SRC-004)

pivotal n

unknown — not stated in the archived sources

endpoint type

unknown — primary endpoint not named in the archived sources; SRC-004 cites overall activity including intracranial responses

approved competitors in class

unknown — not stated in the archived sources (SRC-004 names alectinib as 'a front-line standard of care' and the comparator in the separate first-line ALKAZAR Phase 3)

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

NDA submitted (announced 2026-05-07, SRC-004); accepted for filing with Priority Review in May 2026 (SRC-002)

odac referral

none announced in the archived sources

sponsor state change

Nuvalent was acquired by GSK; acquisition completed (SRC-006, furnished 2026-07-15)