Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers

The FDA's Notice of Funding Opportunity (NOFO), RFA-FD-26-004, seeks novel approaches for therapeutic development in ultra-rare pediatric and adult cancers. The U.S. Food and Drug Administration (FDA) and its Oncology Center of Excellence (OCE) will commit up to $1,500,000 in FY 2026 for 1-3 awards, each potentially receiving up to $500,000 annually for three years. The NOFO aims to advance new tools, methods, or therapeutic approaches broadly applicable to ultra-rare cancers, defined as those with an annual incidence of 300-400 people or less in the U.S. Applications must not propose clinical trials and should focus on regulatory science and decision-making rather than specific product development. Eligibility extends to various organizations, including higher education institutions, non-profits, for-profits, and government entities, but excludes foreign organizations. Key dates include an open date of May 1, 2026, a letter of intent due date of May 18, 2026, and an application due date of June 15, 2026.