Roche’s Columvi (glofitamab) has been granted accelerated approval by the FDA for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma arising from follicular lymphoma who have received two or more prior lines of systemic therapy.
Columvi is a bispecific antibody that targets CD3 on the surface of T cells and CD20 on the surface of B cells. This dual-targeting brings the T cell closer to the B cell, activating the release of cancer cell-killing proteins from the T cell.
The approval of Columvi is based on data from the phase 2b GO29780 study, which showed that 56% of patients treated with Columvi had no signs of cancer or had seen a significant decrease in cancer cells in the body. The most common side effects of Columvi were fatigue, nausea, and infusion-related reactions.
Columvi is the second bispecific antibody to be approved for the treatment of DLBCL. The first bispecific antibody, Epkinly (epcoritamab-bysp), was approved by the FDA in May 2023.
The approval of Columvi provides a new treatment option for patients with relapsed or refractory DLBCL. The drug is expected to be available in the United States in the coming months.
About DLBCL
DLBCL is a type of non-Hodgkin’s lymphoma (NHL). It is the most common type of NHL in adults, accounting for about 40% of cases. DLBCL is a fast-growing cancer that can spread to other parts of the body.
The standard treatment for DLBCL is chemotherapy. However, many patients with DLBCL will relapse or have refractory disease. In these patients, there are limited treatment options available.
About Columvi
Columvi is a bispecific antibody that targets CD3 on the surface of T cells and CD20 on the surface of B cells. This dual-targeting brings the T cell closer to the B cell, activating the release of cancer cell-killing proteins from the T cell.
Columvi is administered as an infusion over 30 minutes. The recommended dose is 300 mg per infusion, given once every two weeks.
The most common side effects of Columvi are fatigue, nausea, and infusion-related reactions. Other side effects include diarrhea, vomiting, headache, and rash.
Conclusion
The approval of Columvi provides a new treatment option for patients with relapsed or refractory DLBCL. The drug is expected to be available in the United States in the coming months.
Morbi lectus risus, iaculis vel, suscipit quis, luctus non, massa. Fusce ac turpis quis ligula lacinia aliquet. Mauris ipsum. Nulla metus metus, ullamcorper vel, tincidunt sed, euismod in, nibh.