Orphan Drug Designation17 Feb 2025 09:34
From RNS 05.09.22 - AVA6000 receives Orphan Drug Designation from FDA.
"The American Cancer Society estimates that, in 2022 approximately 13,190 new soft tissue sarcomas will be diagnosed"
Source - https://www.cancer.org/cancer/types/salivary-gland-cancer/about/what-is-key-statistics.html
How common are salivary gland cancers?
Salivary gland cancers are not very common, making up 6% to 8% of all head and neck cancers in the United States. There are about 2,000 to 2,500 cases in the US each year. They occur at a rate of about 3 cases per 100,000 people per year in the Western world.
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The FDA can grant Orphan Drug Designation (ODD) for more than one indication for a drug, provided each indication is for a rare disease or condition affecting fewer than 200,000 people in the U.S.
Thus Avacta could apply for ODD status forAVA6000 in SGC, they won't get rich on that market though.
However, in the phase two we select one indication, and it's unclear which that will be.
If Soft Tissue Sarcoma is not selected, and Salivary is, then we will be proceed with phase 2 without ODD advantages for Salivary Gland Cancer.
Let's hope accelerated approval for AVA6000 arrives soonest, IMO after phase 1b results.