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4s03b Fda Form

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[Music] welcome back to the Disco fda's drug information soundcast and clinical oncology burst Edition brought to you by fda's division of drug information in partnership with fda's oncology center of excellence today we'll provide a quick update on two recent FDA cancer drug approvals on August 9th 2023 the FDA granted accelerated approval to tal quab tgvs brand named talvi for adults with relapsed or refractory multiple Myoma who have received at least four prior lines of therapy including a proteosome inhibitor an immunomodulatory agent and an anti- cd38 monoclonal antibody efficacy was evaluated in mm101 a single arm open label multicenter study that included 187 patients who had previously received at least four prior systemic therapies patients received talaab tgvs 0.4 mg per kilogram subcutaneously weekly following two step up doses in the first week of therapy or tmab tgvs 0.8 mg per kilogram subcutaneously bi-weekly following three step up doses

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