FDAは新しいコラボ療法を,広域小細胞肺がんの第一回整備治療として承認し,生存率と進行時間の改善を図る. FDA approves new combo therapy as first-line maintenance treatment for extensive-stage small cell lung cancer, improving survival and progression-free time.

FDAは,ラビンキテディンとアテゾリズマブまたはアテゾリズマブとヒアルロンジダゼ-tqjsを,初期治療後に進行しない広範囲小細胞肺がんの成人の第一線維持療法として承認した. The FDA has approved lurbinectedin plus atezolizumab or atezolizumab with hyaluronidase-tqjs as first-line maintenance therapy for adults with extensive-stage small cell lung cancer whose disease hasn’t progressed after initial treatment. 併用薬は,アテゾリズマブ単独投与の2.1カ月と10.6カ月と比較して,進行性疾患のない生存期間を平均5. 4カ月,全生存期間を平均13. 2カ月に改善した. Based on the phase 3 IMforte trial, the combination improved median progression-free survival to 5.4 months and median overall survival to 13.2 months, compared to 2.1 months and 10.6 months with atezolizumab alone. この承認は,この設定に係る第一項の整備的治療を施行するとともに,肝臓の毒性が高まる危険性があり,慎重に患者選択を要する. The approval marks the first maintenance therapy for this setting, offering a significant advance in care, though it carries increased risks of hematologic toxicity, requiring careful patient selection.