Ide-Cel & Enhertu Sponsors Keep Fingers Crossed For EMA Fast-Track
Companies are due to learn this week whether the European Medicines Agency will fast-track its review of their soon-to-be-filed EU marketing applications.
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The European Medicines Agency has agreed to fast track the review of four marketing applications in recent months.The products include AstraZeneca's advanced breast cancer treatment, Enhertu, two investigational CAR-T therapies, and a potential treatment for rare genetic disorders of obesity.
GSK secured accelerated assessment for dostarlimab at the European Medicines Agency but there was no such good news for Merck/AstraZeneca's selumetinib. MYR Pharmaceuticals' bulevirtide has reverted to standard review timelines.
Novel antibody-drug conjugate receives approval in Japan for second-line breast cancer, providing another push to Japanese firm’s strategic plan to build up its oncology operations.