FDA Agreement on Pivotal Trial Design for AVA6000
Avacta Group PLC has announced an agreement with the U.S. Food and Drug Administration (FDA) on the pivotal trial design for faridoxorubicin (AVA6000) in patients with salivary gland cancer, which will serve as a single study with progression-free survival as the sole primary endpoint for full approval. This trial will include both first- and second-line patients in the most prevalent subsets of salivary gland cancer, excluding rarer subsets due to differing natural histories. The FDA previously agreed to lift the lifetime maximum dosing for faridoxorubicin at U.S. sites based on its safety profile and absence of severe cardiac toxicity.
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| LONDON and PHILADELPHIA - June 25, 2026 - Avacta Therapeutics (AIM: AVCT, "the Company", "Avacta"), a clinical stage biopharmaceutical company developing pre | CISION®, a tumor-activated oncology delivery platform, today announces that it has agreed the pivotal trial design for faridoxorubicin (AVA6000, pre | CISION-enabled doxorubicin) with the U.S. Food and Drug Administration (FDA) for a potential full regulatory approval. |
This would comprise a single pivotal study with faridoxorubicin in patients with salivary gland cancer (SGC), with progression-free survival (PFS) as the sole primary endpoint for full approval. Furthermore, the proposed study population includes both first- and second-line patients, in the most prevalent subsets of SGC, while more rare subsets (e.g. undifferentiated histology and mucinous tumor types) are excluded due to differing natural histories.
Christina Coughlin, CEO of Avacta, commented:
"Our recent constructive discussions with the FDA have resulted in a clear path forward for our Gen One product faridoxorubicin towards full approval, based on one pivotal trial with a single primary endpoint of PFS.
"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. It provides further clarity in our continuing conversations with potential partners, with a defined route through clinical development towards potential approval and commercialization.
"The FDA had previously agreed to lifting the lifetime maximum dosing with faridoxorubicin at US sites, based on its excellent safety profile and absence of severe cardiac toxicity. The Company remains committed to progressing faridoxorubicin into further clinical development only with the support of a partner."
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