Poteligeo – pro
The US Food and Drug Administration (FDA) approved mogamulizumab-kpkc (Poteligeo) intravenous (IV) injection for the treatment of adult patients with relapsed/refractory (R/R) mycosis fungoides (MF) or Sézary syndrome (SS) previously treated with at least 1 systemic therapy. The policy criteria are the same as the FDA indication and, considering that the evidence supporting the is new drug is only in previosly treated patients, it is appropriate to use it only according to the indication.
The FDA based its approval on data of the MAVORIC phase 3 (ClinicalTrials.gov Identifier: NCT01728805), in which researchers randomly assigned 372 patients with MF or SS to IV mogamulizumab 1 mg/kg weekly for 4 weeks then every other week thereafter or oral vorinostat 400 mg daily. Results showed that patients in the mogamulizumab arm had a progression-free survival (PFS) of 7.6 months (95% CI, 5.6-10.2) vs 3.1 months (95% CI, 2.8-4.0) in the vorinostat arm (hazard ratio [HR], 0.53; 95% CI, 0.41-0.69; P <.001). So, ti is very effective, and presumably it should also be effective in first line, but we have no trials confirming this, and biologicals sometimes do not follow these logical rules, so awaiting information for first line is appropriate.
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