FDA Approves Glofitamab for Relapsed or Refractory DLBCL

By Kerri Fitzgerald - Last Updated: June 16, 2023

The US Food and Drug Administration (FDA) approved glofitamab-gxbm for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma after two or more lines of systemic therapy.

The accelerated approval was based on results from the phase I/II NP30179 trial that assessed glofitamab as a fixed course for 8.5 months in 132 patients with relapsed or refractory DLBCL. Nearly one-third (30%) of patients had relapsed after prior chimeric antigen receptor T-cell therapy.

The overall response rate with glofitamab treatment was 56% (n=74), with 43% achieving a complete response (n=57). Responses lasted for at least nine months in 68.5% of patients, and the median duration of response was 1.5 years.

The most common adverse events were cytokine release syndrome (70%), musculoskeletal pain (21%), fatigue (20%), and rash (20%).

Glofitamab is the first FDA-approved bispecific antibody for the treatment of relapsed or refractory DLBCL that is given for a defined period of time.

Source: Genentech press release, June 2023

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