FDA grants priority review to loncastuximab tesirine for advanced DLBCL

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Sumary of FDA grants priority review to loncastuximab tesirine for advanced DLBCL:

  • The FDA granted priority review to loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma, according to the agent manufacturer..
  • A phase 2 trial evaluated loncastuximab tesirine for 145 patients with relapsed or refractory DLBCL who received at least two prior lines of therapy..
  • The most common grade 3 or higher treatment-emergent adverse events included neutropenia (25.5%), thrombocytopenia (17.9%), increased gamma-glutamyltransferase (16.6%) and anemia (10.3%)..
  • “The FDA acceptance of our biologics license application and granting of priority review for Lonca is a tremendous accomplishment that brings ADC Therapeutics one step closer to being able to offer patients with relapsed or refractory DLBCL a greatly needed new treatment option in 2021,”…

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