FDA Approves Second Bispecific Antibody for Diffuse Large B-cell Lymphoma

The FDA has given accelerated approval to Genentech’s Columvi (glofitamab-gxbm) to treat adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Large B-cell lymphoma is a fast-growing non-Hodgkin’s lymphoma (NHL) and is one of the most prevalent types of blood cancer among adults in the United States. Patients who relapse have poor outcomes.

Krish Patel, M.D.

“Patients with relapsed or refractory diffuse large B-cell lymphoma may experience rapid progression of their cancer and often urgently need an effective treatment option that can be administered without delay,” Krish Patel, M.D., director of the lymphoma program at the Swedish Cancer Institute in Seattle and investigator of the Columvi NP30179 study, said in a press release.

Columvi will be available in the United States in the coming weeks. The estimated cost is about $350,000 for a fixed-duration treatment that is intended to be completed in 8.5 months (12 treatment cycles). A Genentech spokesperson said they expect Columvi will be covered by Medicare but it is too early to comment on the specifics. The spokesperson also said they are in discussions with multiple payers to determine insurance coverage of Columvi.

Columvi is the third bispecific antibody approved by the FDA for a lymphoma and the second specifically for DLBCL. In May, AbbVie and Genmab’s Epkinly (epcoritamab-bysp) was the first T-cell engaging bispecific antibody to treat patients with DLBCL. Both Epkinly and Columvi target 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.

But Columvi differs from Epkinly in that it is a fixed duration therapy with 12 treatments. Epkinly is a monthly therapy.

Related: Unique New Lymphoma Treatment Priced at $37,500 Monthly

Columvi was approved based on data from the pivotal phase 1/2 NP30179 study. Results showed patients treated with Columvi achieved durable remission, with 56% of patients achieving an overall response and 43% of patients achieving a complete response. The most common adverse events were cytokine release syndrome (70%), musculoskeletal pain (21%), fatigue (20%) and rash (20%). CRS was generally low grade.

Research of Columvi is ongoing. It is being studied in combination with gemcitabine and oxaliplatin (GemOx) versus rituximab in combination with GemOx in patients with second-line plus DLBCL who are ineligible for autologous stem cell transplant. Additional studies are ongoing to investigate the molecule as a monotherapy and in combination with other medicines for the treatment of patients with B-cell non-Hodgkin’s lymphomas, including DLBCL, mantle cell lymphoma and other blood cancers.

In addition, another bispecific antibody from Genentech was granted accelerated approval in December 2022. Lunsumio (mosunetuzumab-axgb) was approved to treat adult patients with relapsed or refractory follicular lymphoma (FL). It is indicated for patients after two or more lines of systemic therapy. Follicular lymphoma is the most common slow-growing form of non-Hodgkin’s lymphoma.