FDA Approves Therapy for Two Rare Types of Non-Hodgkin Lymphoma

The FDA approved mogamulizumab-kpkc for adults with relapsed/refractory mycosis fungoides (MF) or Sézary syndrome (SS)—two rare forms of non-Hodgkin lymphoma—who have received at least one prior systemic therapy. This injectable monoclonal antibody is the first FDA approval for SS. 

The decision was based on results of a clinical trial that included 372 patients with relapsed MF or SS who received mogamulizumab-kpkc or vorinostat. Median progression-free survival was longer for those receiving mogamulizumab-kpkc compared with vorinostat (7.6 vs. 3.1 months). 

#BREAKING: The @US_FDA has approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory #mycosis #fungoides or #Sezary syndrome after at least 1 prior systemic therapy.

READ: https://t.co/zFIomJjkm3 pic.twitter.com/pHZCYpkwnU

— Rare Disease Report (@RareDR) August 8, 2018

The most common adverse events associated with mogamulizumab-kpkc include rash, infusion-related reactions, fatigue, diarrhea, musculoskeletal pain, and upper respiratory tract infection. 

Serious AEs associated with mogamulizumab-kpkc include dermatologic toxicity, infusion reactions, infections, autoimmune problems, and complications of allogeneic hematopoietic cell transplantation following use of mogamulizumab-kpkc. 

The FDA approved pembrolizumab for the treatment of primary mediastinal large B-cell lymphoma. 

The FDA approved encorafenib and binimetinib for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutation. 

Source: U.S. Food and Drug Administration