Good DREAMM-1 Data Keeps GSK On Track For Multiple Myeloma Filing This Year
Confirmation of good trial data for GSK's promising anti-BCMA antibody-drug conjugate GSK2857916 in multiple myeloma patients keeps it in the running for eventual regulatory approval by 2020 - but it faces a formidable field of emerging rival therapies.
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Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.
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.
The DREAMM-2 trial of the antibody-drug conjugate belantamab mafodotin in relapsed/refractory multiple myeloma patients has hit its primary endpoint, giving GSK a chance to file for approval before its BCMA rivals.