News Briefs: Genentech Will Voluntarily Withdraw Gavreto’s RET-Mutant Thyroid Cancer Indication
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Jul 13, 2023
On June 30, Blueprint Medicines Corp. revealed that partner Genentech USA, Inc., a member of the Roche Group, will voluntarily withdraw Gavreto’s (pralsetinib) indication for the treatment of people at least 12 years old with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer who require systemic therapy. The FDA gave the indication accelerated approval on Dec. 1, 2020. Genentech said the decision, which was made in consultation with the FDA, was not due to new safety or efficacy data but rather due to the “feasibility” of conducting the Phase III confirmatory trial required for full approval. Confirmatory studies to convert the other indications of the kinase inhibitor, all of which have accelerated approval, to full approval are ongoing. Read more
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