The Center for Drug Evaluation (CDE) website has indicated that Chia Tai Tianqing’s TQ-B3525, a phosphatidylinositol 3-kinase (PI3-K) α/δ inhibitor, is set to receive priority review status for the treatment of recurrent/refractory follicular lymphoma (FL) as a third-line or later treatment option.
TQ-B3525: A Dual Inhibitor Addressing Drug Resistance
TQ-B3525 is designed as a PI3K catalytic subunit α/δ dual inhibitor, targeting the overcoming of drug resistance that can arise from the up-regulation of 3K subunits due to the inhibition of a single PI3K subunit. This innovative approach significantly reduces toxic side effects compared to pan-PI3K inhibitors. Previous studies have demonstrated TQ-B3525’s outstanding efficacy in the treatment of relapsed/refractory FL and other advanced malignant tumors.
Breakthrough Therapy Designation and Its Implications
The drug was granted breakthrough therapy designation by China’s CDE in July 2021, recognizing its potential to offer a substantial improvement over existing therapies for FL. This designation, coupled with the anticipated priority review status, underscores the drug’s potential impact on the treatment landscape for patients with follicular lymphoma who have exhausted standard therapeutic options.-Fineline Info & Tech
