Gavreto Receives Full FDA Approval
The U.S. Food and Drug Administration (FDA) first gave Accelerated Approval to Gavreto™ (pralsetinib – Genentech/Blueprint Medicines) capsules on Sept. 4, 2020. The original indication for the targeted kinase inhibitor is for treating adult patients who have non-small cell lung cancer (NSCLC) that is verified by an FDA-approved diagnostic test to have rearranged during transfection (RET) fusion mutations. Based on results from a completed clinical trial, that indication now has full FDA approval. In the study, 78% of previously untreated patients and 63% of participants who already had received chemotherapy (chemo) that contains platinum responded to treatment with Gavreto. Response times averaged 13.4 months and 38.8 months, respectively. A second Accelerated Approval was granted on Dec. 1, 2020, to treat patients who are 12 years old and older and who need systemic treatment for metastatic or progressed RET+ thyroid cancer that cannot be treated by radioactive iodine. Clinical study confirmation for RET+ thyroid cancer still is pending. A second part of the Accelerated Approval for thyroid cancer — for treating RET+ medullary thyroid cancer (MTC) — was rescinded in July 2023, after further testing did not support Gavreto’s effectiveness for MCT. For both remaining indications, once-daily dosing is recommended at 400mg (four capsules) — at least two hours after and one hour before any food intake. A similar drug, Retevmo™ (selpercatinib – Loxo Oncology) capsules have full FDA approval for treating RET+ NSCLC, as well as Accelerated Approvals for the same two thyroid cancers that Gavreto originally had, and for RET-fusion+ solid tumors that worsen despite prior treatment or that do not have alternate treatments. Gavreto’s revised prescribing information is here.