The USFDA has approved selpercatinib, a kinase inhibitor , for treating adult patients with metastatic or locally advanced solid tumors with a rearranged during transfection (RET) gene fusion . The accelerated approval was granted based on the efficacy of the drug reported in the LIBRETTO-001 clinical trial. The drug is recommended for patients with progressive tumors following prior systemic treatment or patients with no alternative treatment options.
A 44% overall response rate at 24.5 months was observed among 41 patients with RET fusion-positive tumors (other than thyroid cancer and non-small cell lung cancer (NSCLC)). Types of tumors that responded to the drug were pancreatic adenocarcinoma (27%), colorectal (24%), salivary (10%), and unknown primary (7%). The efficacy evaluation was further strengthened by the data collected from 343 patients with RET fusion-positive thyroid…
