China approves the world’s first CAR-T therapy for a solid tumor. Hours later, the FDA responds with full approval of afami-cel and expansion into pediatric synovial sarcoma. A remarkable day for cellular therapy. 🇨🇳 Satri-cel (CLDN18.2 CAR-T) CT041-ST-01, refractory gastric/GEJ cancer • PFS: 3.25 vs 1.77 months (HR 0.37) • OS: 7.9 vs 5.5 months (HR 0.69) • 18-month OS: 20.1% vs 8.6% • First CAR-T ever approved for a solid tumor 🇺🇸 Afami-cel (MAGE-A4 TCR-T) SPEARHEAD-1, advanced synovial sarcoma • ORR: 43% • CR: 4.5% • Median DoR: 6.0 months • Median OS: 15.4 months • First FDA-approved engineered cellular therapy for a solid tumor For decades, solid tumors were where cellular therapies went to fail. Now, on the same day, regulators in China and the United States have approved two different engineered T-cell platforms for two different solid tumors. A brave new world for solid tumor oncology. Any cancer center not providing cellular therapies is going to be left in the dust. @OncoAlert @TheGutOncLab @Onco_Nexus