Call Us: 888-488-5750

Pharmacy Bulletin

Pharmacy Bulletin

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

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 A second part of the Accelerated Approval for thyroid cancer — for treating RET+ medullary thyroid cancer (MTC) — was rescinded in July 2023, after further testing did not support Gavreto’s effectiveness for MCT.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.