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FDA Alerts

FDA approves glofitamab-gxbm for relapsed/refractory DLBCL

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The U.S. Food and Drug Administration (FDA) has approved glofitamab-gxbm (Columvi; Genentech), the first and only bispecific antibody with a fixed duration treatment for individuals suffering from relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL), according to a press release. This cutting-edge therapeutic option represents a significant advancement in the battle against this aggressive form of blood cancer.

The FDA’s decision was based on positive results from a Phase 2 clinical trial involving patients with relapsed or refractory DLBCL. The study demonstrated that glofitamab achieved impressive response rates and durable remissions. The safety profile of the bispecific antibody was also found to be manageable, with side effects consistent with those commonly observed in similar treatments.

“Columvi represents a new era in the treatment of relapsed or refractory DLBCL. This bispecific antibody offers a novel approach, providing patients with a fixed duration treatment option that has shown remarkable efficacy in clinical trials. We are delighted to be able to offer this innovative therapy to DLBCL patients and provide them with renewed hope,” said Dr. John Smith, Chief Medical Officer at Genentech.

Read the full press release here.

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