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Gavreto FDA Approval History

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 for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion- positive non-small cell lung cancer (NSCLC), and adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC).

Development Timeline for Gavreto

DateArticle
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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