Yuantai Pharmaceuticals' Yiganthai has received official early approval from the FDA for the addition of HCC indications, making it the only SIRT product in the world with dual FDA-approved indications.

date
08/07/2025
On July 7th, Farxiga Pharmaceuticals announced that the groundbreaking interim data from the DOORwaY90 clinical trial of yttrium [90Y] microsphere injection successfully met the pre-specified primary endpoints. The FDA has formally approved the addition of a new indication for this product, for the treatment of unresectable hepatocellular carcinoma (HCC), without limitation on tumor size. This marks SIR-Spheres yttrium [90Y] microsphere injection as the first and only selective internal radiation therapy product approved by the FDA for dual indications of unresectable HCC and liver metastases from colorectal cancer globally.