FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions.

doi:10.1158/1078-0432.CCR-21-0967

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FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions.

Clinical cancer research : an official journal of the American Association for Cancer Research - 15 Oct 2021

Kim Janice, Bradford Diana, Larkins Erin, Pai-Scherf Lee H, Chatterjee Somak, Mishra-Kalyani Pallavi S, Wearne Emily, Helms Whitney S, Ayyoub Amal, Bi Youwei, Sun Jielin, Charlab Rosane, Liu Jiang, Zhao Hong, Liang Dun, Ghosh Soma, Philip Reena, Pazdur Richard, Theoret Marc R, Beaver Julia A, Singh Harpreet

Abstract excerpt

The FDA granted accelerated approval for pralsetinib on September 4, 2020 for non-small cell lung cancer (NSCLC) and December 1, 2020 for thyroid cancer, for: (i) adult patients with metastatic RET fusion-positive NSCLC, (ii) adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy, and (iii) adult and pediatric patients ≥12 years...

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PMID: 34045295
DOI: 10.1158/1078-0432.CCR-21-0967

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