The FDA has granted regular approval to pralsetinib (Gavreto®, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion–positive non–small cell lung cancer (NSCLC) as detected by an FDA-approved test. Previously, pralsetinib was granted accelerated approval for the NSCLC indication on September 4, 2020, based on the initial overall response rate and duration of response findings in 114 patients. Based on data of the addition of 123 patients and 25 months of...

The FDA has approved pralsetinib (GAVRETOTM, Blueprint Medicines Corporation) for adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) that requires systemic therapy and for patients with RET fusion-positive thyroid cancer who require systemic therapy and whose disease is refractory to radioactive iodine therapy. The approval was based on ARROW (NCT03037385), an open label, multi-cohort phase 1/2 clinical trial led by f...

The FDA has granted accelerated approval to pralsetinib (GavretoTM, Blueprint Medicines Corporation), an oral selective RET kinase inhibitor, for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by the OncomineTM Dx Target (ODxT) Test (Life Technologies Corporation), which has also been approved as a companion diagnostic. RET alterations are implicated in 1% to 2% of NSCLC cases, as well as in a number of other cancer types. The pralsetin...