Will the FDA approve Cullinan Therapeutics's zipalertinib for Locally advanced or metastatic EGFR exon 20 insertion NSCLC after platinum chemotherapy by March 13, 2027?
deadline 2027-03-13
confidence medium
tier 4 evidence
80%PolySignal estimate
Resolution criterion
Yes if the FDA approves zipalertinib for the indication stated above (Drugs@FDA entry, FDA announcement or Cullinan Therapeutics press release) no later than March 13, 2027. A complete response letter, an extension of the PDUFA date or the absence of a decision by then counts as no. An accelerated or conditional approval counts as an approval; a later label update does not change the outcome.
Verified starting state
As of October 12, 2026: according to the Cullinan Therapeutics filing of October 2, 2026, the FDA has set a PDUFA target action date of February 27, 2027. Source: https://www.sec.gov/Archives/edgar/data/1789972/000119312526411011/cgem-ex99_1.htm
What pushes it up
- PDUFA target action date of February 27, 2027 indicates FDA expects to approve before the March 13, 2027 deadline [tier 4]
What pushes it down
- Combination therapy and rare indication may introduce regulatory complexity, lowering approval odds compared to single agents [tier 4]
- No prior approvals or clinical data beyond phase 3 results are publicly available, increasing uncertainty [tier 4]
What would move this number most
Whether the FDA will meet the target action date and approve the drug by March 13, 2027
How this number is built
| Deadline | 2027-03-13 |
| Base rate | 87% |
| Best evidence | tier 4 · 5 article(s) used |
| Independent runs | 79 · 80 (spread 1 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-10-12 15:58 |
| Model | openai/gpt-oss-20b (Groq) |
Sources consulted