FDA grants accelerated approval to selpercatinib for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumors

發(fā)布時(shí)間： 2024-06-14 閱讀：485次

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June 3, 2024 -the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older with the following:

• advanced or metastatic medullary thyroid cancer      (MTC) with a RET mutation, as detected by an FDA-approved      test, who require systemic therapy;

• advanced or metastatic thyroid cancer with      a RET gene fusion, as detected by an FDA-approved test,      who require systemic therapy and who are radioactive iodine-refractory (if      radioactive iodine is appropriate); and

• locally advanced or metastatic solid tumors      with a RET gene fusion, as detected by an FDA-approved      test, that have progressed on or following prior systemic treatment or who      have no satisfactory alternative treatment options.

This is the first FDA approval of a targeted therapy for pediatric patients < 12 years of age with RET alterations. Selpercatinib was previously granted accelerated approval for the thyroid cancer indications in adults and pediatric patients 12 years of age and older. It also was previously granted accelerated approval for the solid tumor indication in adults.