Myeloma BCMA Therapy In Spotlight: EMA Considers Fast Tracking GSK Filing
EU Filing Understood To Be Expected in H1 2020
The European Medicines Agency is this week deciding whether GlaxoSmithKline’s planned EU marketing application for its BCMA-targeting therapy merits an accelerated assessment.
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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.
EU Accelerated Assessment Tracker
The European Medicines Agency this year is known to have granted ten requests for accelerated assessment of planned EU marketing authorization applications. Nine such requests are known to have been rejected. As 2019 draws to a close, the outcomes of five requests are still unknown.
GSK Files Its BCMA Drug In Multiple Myeloma
GSK has filed its anti-BCMA agent with the FDA after full Phase II DREAMM-2 data showed an overall response rate of 31% in patients with heavily pre-treated multiple myeloma.