Avacta Group (AIM:AVCT), a clinical-stage biopharmaceutical company developing tumour-activated cancer therapies, has secured FDA agreement on a pivotal trial design for faridoxorubicin (AVA6000) that could support full regulatory approval in salivary gland cancer patients.
The agreed design requires a single pivotal study with progression-free survival as the sole primary endpoint, covering both first- and second-line patients across the most prevalent salivary gland cancer subtypes.
"This would allow the company to move directly to the pivotal trial when the Phase 1b data are mature, enabling time savings with the clear focus on PFS data to secure approval," said Christina Coughlin, Avacta's chief executive.
The FDA had previously agreed to lift the lifetime maximum dosing restriction on faridoxorubicin at US sites, citing its safety profile and absence of severe cardiac toxicity, a meaningful distinction from conventional doxorubicin.
Coughlin noted the clarity this provides for ongoing partnership discussions, with a defined clinical development route now established toward potential approval and commercialisation.
Avacta has stated it will only advance faridoxorubicin into the pivotal trial with the support of a partner, making the progress of those partnering conversations the next material milestone to watch.
