Antibody-Drug Coupling Belantamab Mafodotin: Alarming Eye Toxicity
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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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!---- briefing at a panel of FDA advisory panels on July 14, noted that GlaxoSmithKline's antibody-drug conjugate (ADC) Belantamab mafodotin is highly toxic to the eye, which is the main safety risk of Belantamab mafodotinFDA reviewer sedators said that while the results of the dreamM-2 key trial showed significant effectiveness in treating patients with recurrent refractive multiple myeloma, the incidence and severity of corneal lesions in patients were "very high" and it was not clear whether the benefits were higher than the riskdrugmakers are seeking a therapeutic dose of 2.5 mg / kg for patients with recurrent refractory multiple myeloma who have previously received at least four treatments, including anti-CD38 monoclonal antibodies, protease inhibitors, and immunomodulatorsGlaxoSmithKline said Belantamab mafodotin would be the first anti-BCMA drug in the United States if approvedDREAMM-2 trials showed that Belantamab mafodotin reached the primary endpoint, with an overall remission rate (ORR) of 31% in the 2.5 mg / kg dose queue and 34% for the 3.4 mg / kg dose group
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