Posted: 28 November 2025
Amplia Therapeutics Limited announced that positive feedback had been received from the United States Food and Drug Administration (FDA) following a recent Type D meeting, providing support for the company’s planned late-stage clinical trial of narmafotinib for pancreatic cancer.
Amplia noted that the FDA had endorsed the proposed two-dose comparison planned for the Phase 2b component of the study, which would precede a pivotal Phase 3 stage. According to Amplia CEO and Managing Director Dr Chris Burns, “FDA’s response supports the dose comparison design of the Phase 2b portion of this trial prior to the pivotal Phase 3 stage. We see this as a positive outcome as the changes proposed will have minimal impact to the trial timeline.”
The meeting outcome was characterised as favourable, with the regulator’s clarifications providing confidence that the trial remained on track for commencement in late 2026. Minor adjustments suggested by the agency were described as having minimal effect on projected timeframes.
The planned registration-enabling Phase 2b/3 trial is expected to evaluate narmafotinib—Amplia’s lead candidate—in combination with gemcitabine and Abraxane® for the treatment of pancreatic cancer. Narmafotinib’s dose optimisation strategy, a key focus of the Type D interaction, was confirmed as acceptable to the FDA, enabling the company to proceed with its next steps.
In light of the feedback, a full protocol for the study is being prepared for FDA review in the first half of 2026, aligning with Amplia’s goal to advance to trial initiation later that year.
A Type D meeting is a formal FDA mechanism enabling sponsors to obtain targeted advice on specific regulatory matters outside the standard review cycle, helping guide development plans for complex clinical studies.
