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Gavreto FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 22, 2023.

FDA Approved: Yes (First approved September 4, 2020)
Brand name: Gavreto
Generic name: pralsetinib
Dosage form: Capsules
Company: Genentech, Inc.
Treatment for: Non-Small Cell Lung Cancer, Thyroid Cancer

Gavreto (pralsetinib) is an oral selective RET kinase inhibitor used for the treatment of rearranged during transfection (RET) fusion- positive non-small cell lung cancer (NSCLC), and RET-mutant medullary thyroid cancer (MTC).

Development timeline for Gavreto

Aug  9, 2023Approval FDA Grants Regular Approval for Gavreto (pralsetinib) for Non-Small Cell Lung Cancer with RET Gene Fusions
Dec  1, 2020Approval Genentech Announces FDA Approval of Gavreto (pralsetinib) for People With Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers
Sep  4, 2020Approval FDA Approves Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Jul  1, 2020Blueprint Medicines Announces Submission of New Drug Application to FDA for Pralsetinib for the Treatment of Advanced RET Mutant and RET Fusion-Positive Thyroid Cancers
Jan  8, 2020Blueprint Medicines Announces Top-line Data for Pralsetinib and Initiates Rolling NDA Submission to FDA for the Treatment of Patients with RET Fusion-Positive Non-Small Cell Lung Cancer
Jun  3, 2019Blueprint Medicines' Highly Selective RET Inhibitor BLU-667 Shows Durable Anti-Tumor Activity in Patients with RET-Altered Cancers in Updated ARROW Trial Data Presented at ASCO 2019

Further information

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