Selpercatinib Approved for RET Fusion–Positive Solid Tumors

The FDA has granted accelerated approval to selpercatinib (Retevmo®, Eli Lilly and Company) for treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) gene fusion solid tumors that have progressed on prior systemic therapy, or who have no adequate alternative treatment options. "Selpercatinib, a highly selective RET kinase inhibitor with central nervous system (CNS) activity, was developed specifically to treat patients with RET-altered cancers," wro...

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Selpercatinib Approved for RET Fusion-Positive Non-Small Cell Lung Cancer

The FDA has granted regular approval selpercatinib (Retevmo®, Eli Lilly and Company) for treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) gene fusion non-small cell lung cancer (NSCLC). Selpercatinib previously received an accelerated approval from the FDA based on its initial trial results in May 2020. This comes in combination with an FDA approval of the Oncomine Dx Target (ODxT) Test (Thermo Fisher Scientific) as a companion diagnostic for s...

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Pralsetinib Approved: RET Fusion-Positive Non-Small Cell Lung Cancer

The FDA has granted accelerated approval to pralsetinib (GavretoTM, Blueprint Medicines Corporation), an oral selective RET kinase inhibitor, for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by the OncomineTM Dx Target (ODxT) Test (Life Technologies Corporation), which has also been approved as a companion diagnostic. RET alterations are implicated in 1% to 2% of NSCLC cases, as well as in a number of other cancer types. The pralsetin...

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