FDA grants regular approval to pralsetinib for RET fusion-positive metastatic NSCLC
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The FDA has granted regular approval to pralsetinib (Gavreto, Genentech) for adult patients with metastatic RET fusion-positive non-small cell lung cancer. The approval was issued on August 9, 2023, and applies to a biomarker-defined subset of NSCLC patients whose tumors carry RET gene fusions. Pralsetinib is a targeted therapy designed for this specific alteration. The regulatory decision establishes the drug as an approved option in this setting, though broader questions such as positioning relative to other RET-directed agents and long-term outcomes remain outside the scope of the announcement.
Written by a model from the reports · updated 3 hours ago
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- U.S. FDAPickFDA approves pralsetinib for non-small cell lung cancer with RET gene fusions
On August 9, 2023, the FDA granted regular approval to pralsetinib (Gavreto, Genentech) for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).
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