Targeting BCMA's ADC drug belantamab mafodotin, supported by an FDA advisory panel to treat patients with recurrent or refractive multiple myeloma
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Last Update: 2020-07-16
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Source: Internet
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Author: User
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!---- The FDA advisory panel voted 12 to 0 tuesday in favor of targeting GlaxoSmithKline's antibody-drug conjugate (ADC) belantamab mafodotin to treat patients with recurrent or refractory multiple myeloma (RRMM)Photo Source: GSK has been working on developing new treatments for patients who have received at least four previous treatments, including anti-CD38 monoclonal antibodies, protease inhibitors and immunomodulatorspanel vote, a recent FDA report questioned whether the drug's benefits outweighed the risk of eye toxicity observed in the critical DREAMM-2 trialthey noted that corneal lesions were the most common adverse event in the study, with a total incidence of 71%, while 44% of patients experienced at least one severe corneal lesions at a dose of 2.5 mg/kgkey DREAMM-2 study, the drug achieved a total remission rate (ORR) of 31 percentGSK says corneal lesions can be partially controlled by dose adjustments, adding that "no permanent corneal ulcers will be caused."the European Medicines Agency is also speeding up the approval of belantamab mafodotin marketing applications
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