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FDA approved mogamulizumab for adult patients with relapsed or refractory CTCL
By: News Feed | Last updated: 9th August 2018 | In: Chemotherapy, Haematology, Oncology, US FDA Onc\Haem Approvals
CCR4, CTLC, FDA, Kyowa Kirin, lymphoma, mogamulizumab, mycosis fungoides, Poteligeo, Sézary syndrome
On the 8th of August 2018, the FDA approved mogamulizumab-kpkc (Poteligeo®, Kyowa Kirin), a CC chemokine receptor type 4 (CCR4) directed monoclonal antibody, for use in adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL).
In a randomised, open-label, multicentre trial (Study 0761-010; NCT01728805), 372 relapsed or refractory cutaneous mycosis fungoides (MF [55%]) or Sézary syndrome (SS [45%]) patients were randomised to either mogamulizumab or vorinostat. The participants had received a median of 3 prior therapies.
The median PFS was 7.6 months (95% CI, 5.6-10.2) vs 3.1 months (95% CI, 2.8-4.0) for mogamulizumab-kpkc vs vorinostat arm (HR=0.53; 95% CI, 0.41-0.69; p<0.001), respectively. The confirmed overall response rate was 28% and 5%, respectively (p<0.001).
Common, all-grade, adverse reactions in ≥20% of patients included rash, infusion-related reactions, fatigue, diarrhoea, musculoskeletal pain, and upper respiratory tract infection. Serious adverse reactions occurred in 36% of patients, most often (16% of patients) from infection. Prescribing physicians should be alert for dermatologic toxicities, infusion reactions, infections, autoimmune complications, and complications of allogeneic haematopoietic stem cell transplantation, including severe and refractory graft-versus-host disease.
This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
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