Avacta Therapeutics (AIM: AVCT) has secured a significant regulatory milestone after reaching an agreement with the US Food and Drug Administration on the pivotal trial design for its lead cancer therapy, faridoxorubicin (AVA6000), potentially accelerating its route to market.
The FDA has agreed that a single pivotal clinical trial could be sufficient to support full regulatory approval of AVA6000 for the treatment of salivary gland cancer, with progression-free survival serving as the sole primary endpoint.
The proposed study will enrol both first-line and second-line patients with the most common forms of salivary gland cancer, while excluding rarer tumour subtypes that follow different clinical courses.
The agreement provides Avacta with a clearly defined regulatory pathway, allowing the company to move directly into a pivotal trial once data from the ongoing Phase 1b study have matured. This removes the need for an additional intermediate study and has the potential to shorten the overall development timeline.
The latest development builds on previous FDA agreement to remove the lifetime maximum dosing limit for AVA6000 at US clinical sites, following encouraging safety data showing no evidence of severe cardiac toxicity, a key limitation of conventional doxorubicin chemotherapy.
Chief Executive Christina Coughlin said the FDA discussions have established a clear route towards potential approval and commercialisation, adding that the simplified clinical pathway also provides greater certainty in ongoing partnership discussions.
Avacta has previously stated that it intends to advance AVA6000 into late-stage development only with the support of a commercial partner, and the regulatory clarity is expected to strengthen those negotiations.
For investors, the announcement represents one of the most important regulatory milestones for AVA6000 to date. Agreement on a single pivotal study significantly de-risks the clinical development pathway, reduces potential time to market and enhances the commercial attractiveness of Avacta’s tumour-activated pre|CISION® platform.
