
FDA, Telix Agree on NDA Resubmission Pathway for Glioma Imaging Agent
Key Takeaways
- Telix will resubmit the NDA for TLX101-CDx with a confirmatory efficacy study to meet FDA's request for additional evidence.
- The FDA recognizes glioma imaging as an unmet medical need and may expedite the review upon successful resubmission.
Telix will now include an additional, confirmatory efficacy study analysis of existing data, hoping to satisfy FDA’s request for supplemental evidence and address concerns raised in a complete response letter.
Melbourne-based
What additional information does FDA want?
In a press release, Telix said it engaged with FDA and received detailed feedback regarding a resubmission package, which Telix said will include an additional, confirmatory efficacy study that analyzes existing data (1). Telix said it believes this study will satisfy FDA’s request for supplemental evidence to bolster the NDA and address matters raised in a complete response letter (CRL) issued for TLX101-CDx.
FDA has acknowledged that glioma imaging is an unmet medical need and that an expedited review is likely upon successful resubmission, according to the press release (1).
While TLX101-CDx has not received a marketing authorization in any jurisdiction, Telix said it remains committed to providing patient access to the imaging agent, through an FDA-approved expanded access program, until regulatory approval is granted in the United States (1).
“As previously advised, Telix had multiple options for delivering additional data requested by FDA in the CRL response,”
How is FDA increasing transparency efforts?
In July 2025, FDA said it would be
At that time, Pharmaceutical Technology® Group
What else is Telix working on?
As for Telix, in January 2025
Telix plans to resubmit the NDA for TLX101-CDx in the fourth quarter of 2025; if the resubmission is successful, FDA will subsequently set a new Prescription Drug User Fee Act goal date (1).
References
1. Telix Pharmaceuticals.
2. FDA.
3. Cole, C.
4. FDA.
5. Telix Pharmaceuticals. Telix to Acquire Next-Generation Therapeutic Assets and Innovative Biologics Technology Platform. Press Release. Jan. 13, 2025.
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