The FDA has granted accelerated approval to talquetamab-tgvs, a first-in-class bispecific antibody targeting the GPRC5D receptor, for heavily pretreated adults with relapsed or refractory multiplemyeloma. MedicalNews
of 187 patients who had previously been treated with at least four prior systemic therapies.
The overall response rate in 100 patients who received a subcutaneous dose of 0.4 mg/kg weekly was 73% and median duration of response was 9.5 months. The overall response rate in 87 patients who received a subcutaneous dose of 0.8 mg/kg biweekly was 73.6% with about 85% of responders maintaining their response for at least 9 months. In this group, the median duration of response was not estimable.
Patients in the 0.4 mg/kg weekly dose group were treated following two step-up doses in the first week of therapy, and those in the 0.8 mg/kg biweekly group were treated following three step-up doses, until disease progression or unacceptable toxicity. Adverse reactions occurring in at least 20% of the 339 patients in the safety population included CRS, dysgeusia , nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, pyrexia, xerosis,
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