1 December 2020 - Today the Food and Drug Administration approved pralsetinib (Gavreto, Blueprint Medicines) for adult and pediatric patients 12 years of age and older with advanced or metastatic RET mutant medullary thyroid cancer who require systemic therapy or RET fusion positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

This review used the Real-Time Oncology Review pilot program and Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 3 months ahead of the FDA goal date.

Read FDA press release