RE: Single pivotal trial, with progression-free survival as primary endpoint needed for full approval25 Jun 2026 07:41
The key takeaway is that the FDA has agreed Avacta may only need a single pivotal trial for full approval of AVA6000 in salivary gland cancer, with progression free survival as the sole primary endpoint. That potentially removes the need for multiple registrational studies, reducing development time, cost and regulatory risk while providing a much clearer path to market.