Will the FDA approve neladalkib (NVL-655) for ALK-positive non-small cell lung cancer?
deadline 2026-11-27
confidence low
tier 2 evidence
55%Asturna estimate
Resolution criterion
Resolves YES if the FDA publishes an approval (Drugs@FDA or an official Nuvalent press release) for neladalkib in TKI-pretreated, advanced ALK-positive NSCLC on or before 27 November 2026. A complete response letter, a postponement of the PDUFA date, or the absence of a decision count as no. An approval restricted to a narrower prior-treatment subgroup than described counts as no; flag for manual review if unclear.
Verified starting state
NDA accepted with Priority Review, PDUFA date 27 November 2026, based on efficacy data from the ALKOVE-1 trial in TKI-pretreated ALK-positive NSCLC patients. Fourth-generation ALK inhibitor; the mechanism class (ALK inhibition) already has approved drugs (alectinib, lorlatinib). (Nuvalent press release / OncLive, 27 May 2026)
What pushes it up
- The NDA was accepted with Priority Review, which historically correlates with a higher first-cycle approval rate than standard reviews [tier 1 starting state].
- The ALK inhibition mechanism is well-established and validated by existing approved therapies like alectinib and lorlatinib, lowering biological risk [tier 1 starting state].
What pushes it down
- The PDUFA date is exactly on the deadline of November 27, 2026; any regulatory extension (typically 3 months for major amendments) would result in a 'No' resolution [tier 1 starting state].
- Recent regulatory precedents show that lung cancer filings can face unexpected FDA pushback leading to withdrawals or delays [tier 2, article 19].
What would move this number most
The primary uncertainty is whether the FDA will approve the drug on or before the PDUFA date without any review extensions, as any delay past November 27, 2026, triggers a 'No' resolution.
How this number is built
| Deadline | 2026-11-27 |
| Base rate | 40% |
| Best evidence | tier 2 · 1 article(s) used |
| Independent runs | 48 · 48 · 55 · 60 · 80 (spread 32 pts) |
| Confidence | low |
| Evidence cap | not triggered |
| Last revised | 2026-10-09 09:01 |
| Model | gemini-3.5-flash |
Sources consulted
Probability history
2026-10-09 09:01 55% 57 article(s) on file · gemini-3.5-flash
- What pushes it up. The NDA was accepted with Priority Review, which historically correlates with a higher first-cycle approval rate than standard reviews [tier 1 starting state].
- What pushes it up. The ALK inhibition mechanism is well-established and validated by existing approved therapies like alectinib and lorlatinib, lowering biological risk [tier 1 starting state].
- What pushes it down. The PDUFA date is exactly on the deadline of November 27, 2026; any regulatory extension (typically 3 months for major amendments) would result in a 'No' resolution [tier 1 starting state].
- What pushes it down. Recent regulatory precedents show that lung cancer filings can face unexpected FDA pushback leading to withdrawals or delays [tier 2, article 19].
- What would move this number most. The primary uncertainty is whether the FDA will approve the drug on or before the PDUFA date without any review extensions, as any delay past November 27, 2026, triggers a 'No' resolution.
2026-10-06 09:17 48% 40 article(s) on file · openai/gpt-oss-120b (Groq)
- What pushes it up. NDA accepted with Priority Review and a PDUFA decision date set for 27 Nov 2026, which historically correlates with a high likelihood of approval [1]
- What pushes it up. The drug belongs to the ALK inhibitor class, which already has multiple FDA‑approved agents, indicating a well‑understood regulatory pathway [1]
- What pushes it up. Priority Review shortens the review timeline and is typically granted to drugs with strong efficacy data, further increasing approval odds [1]
- What pushes it down. FAERS reports five serious adverse events for neladalkib, suggesting potential safety concerns that could delay or block approval [1]
- What would move this number most. Whether any new safety data or an FDA advisory committee recommendation emerges before the PDUFA date could significantly shift the outcome.
2026-09-22 00:42 44% 4 article(s) on file · qwen/qwen3.8-27b (Groq)
Reasons not recorded for this revision (detailed history has only been kept since recently).