FDA approves Retevmo for locally advanced or metastatic RET fusion-positive solid tumors, NSCLC

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FDA has granted regular approval to Retevmo (selpercatinib) adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

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Follow-up results from the phase Ib/II CHRYSALIS-2 study cohort evaluating the safety and tolerability of the combination of Rybrevant (amivantamab-vmjw)—a bispecific antibody targeting epidermal growth factor receptor and mesenchymal-epithelial transition—with lazertinib, an oral third-generation EGFR tyrosine kinase inhibitor, plus platinum-based chemotherapy (carboplatin and pemetrexed) in patients with relapsed/refractory non-small cell lung cancer and EGFR mutations, showed that the drug combination led to durable progression-free survival.