AGP Executive Report
Last update: 10 hours agoCLL Treatment Update (EU/EEA): AbbVie says the European Commission has expanded the VENCLYXTO (venetoclax) label to allow fixed-duration first-line combinations with acalabrutinib (with or without obinutuzumab) and with ibrutinib—covering EU states plus Iceland, Norway, and Liechtenstein. Bladder Cancer (EU/EEA): The EU CHMP issued a positive opinion for perioperative pembrolizumab plus enfortumab vedotin, followed by adjuvant therapy after radical cystectomy for cisplatin-ineligible muscle-invasive bladder cancer; a final EC decision is expected in Q3 2026 for EU, Iceland, Liechtenstein, and Norway. Transplant Outcomes (Europe): Hansa Biopharma reports 90% one-year graft failure-free survival with Idefrix (imlifidase) in highly sensitised kidney transplant patients, with patient survival at 98% in a European post-authorisation study. Rare Immunodeficiency (EU/EEA): Pharming received EU marketing authorization for Joenja (leniolisib) for activated PI3K delta syndrome, approved for ages 12+ across the EU plus Norway, Iceland, and Liechtenstein. Health Access & Travel Rules (UK): The UK DWP confirms strict Personal Independence Payment holiday rules for trips over four weeks, warning of fines or payment stops if claimants don’t report changes.
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