Submit a BLA for lifileucel (TIL therapy) for metastatic melanoma
Delivered after the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 25 Feb 2021
- Due
- 31 Dec 2021
- Delivered
- August 2022
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“The BLA submission is anticipated during 2021.”
What we found
Evidence strength A What the grades mean
The company did not submit the BLA in 2021. It later initiated a rolling BLA submission in August 2022, with completion expected in Q4 2022.
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A Iovance Biotherapeutics, Inc. 10-Q filed 2022-05-05
“we expect to request a pre-BLA meeting in July 2022 and to complete a BLA submission for lifileucel in metastatic melanoma by August 2022.” ✓ confirmed on the page
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A Iovance Biotherapeutics, Inc. 10-Q filed 2022-11-03
“We initiated a rolling Biologics License Application, or BLA, submission to the U.S. Food and Drug Administration, or FDA, for lifileucel in August 2022, and we expect to complete the BLA submission in the fourth quarter of 2022.” ✓ confirmed on the page
Checked 27 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory submission
- Indicative materiality
- High rules
- Action
- Submit
- Deliverable
- BLA submission for lifileucel in metastatic melanoma
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- Medium
- Specificity
- Medium
- Depends on
- Regulatory
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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Report an error in this entry Reference: KI-C-2021-IOVA-024435 · Corrections policy