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ArticleFDA Updates

FDA approves Talquetamab for multiple myeloma

The USA FDA approves Talquetamab, a first-in-class bispecific antibody targeting the GPRC5D receptor, for heavily pretreated adults with relapsed or refractory multiple myeloma.

Indication for usage: Patients must have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Dose: Both the weekly 0.4 mg/kg and biweekly 0.8 mg/kg doses are recommended. Check out the full regimens.

Adverse effects: CRS, dysgeusia, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, pyrexia, xerosis, dysphagia, upper respiratory tract infection & diarrhea.

Talquetamab was evaluated in the single-arm, open-label MonumenTAL-1 study of 187 patients who had previously been treated with at least four prior systemic therapies.

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