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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Genentech, a member of the Roche Group, announced that the phase II/III SKYSCRAPER-06 study evaluating tiragolumab plus Tecentriq (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not meet its primary endpoints of progression-free survival at its primary analysis with a hazard ratio of 1.27 [95% CI: 1.02,1.57] and overall survival at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature.