AGP Executive Report
Last update: 12 hours agoRett syndrome breakthrough (EU): Acadia’s DAYBU® (trofinetide) won a positive CHMP recommendation for approval in the EU to treat neurobehavioral symptoms of Rett syndrome in adults and children aged 5+. If the European Commission follows, it would be the first EU therapy for this specific indication, based mainly on the Phase 3 LAVENDER study showing improvements on key symptom scales. Bladder cancer care (EU): Merck/MSD’s Keytruda® plus Padcev® secured EU approval for adults with resectable muscle-invasive bladder cancer who can’t receive cisplatin, using a perioperative approach (before and after surgery) and reporting major gains in event-free survival and pathologic complete response. Breast cancer option (EU): Gilead’s Trodelvy® (sacituzumab govitecan) was approved by the European Commission as first-line monotherapy for certain adults with unresectable or metastatic triple-negative breast cancer not eligible for PD-(L)1 inhibitor therapy. Heat and schools (Europe): A record heatwave is forcing schools to close or shorten days across parts of Europe, with limited cooling options leaving classrooms struggling to protect children. Travel health reminder (UK/EU): Luton Airport warned holidaymakers returning to Great Britain that some meat and dairy items from the EU are illegal to bring back, with confiscation and possible fines.
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