GenentechThe FDA has approved Genentech‘s Lunsumio (mosunetuzumab-axgb), a novel bispecific antibody for relapsed or refractory follicular lymphoma (R/R FL).

The indication covers R/R FL patients who have received at least two prior systemic therapies. 

Patients with the cancer subtype have had limited treatment options and significant morbidity and mortality. 

The approval of Lunsumio is the first time the FDA has approved a bispecific antibody to treat one of the most common slow-growing forms of non-Hodgkin’s lymphoma.

Lunsumio is a CD20xCD3 T-cell-engaging bispecific antibody. 

Priority review and breakthrough therapy designation

FDA granted priority review to Lunsumio this summer. The agency granted it breakthrough therapy designation (BTD) in 2020. 

In the pivotal Phase 2 GO29781 study, 60% (54/90) of Lunsumio recipients who received at least two prior therapies had complete remission. A total of 80% (72/90) of patients had a durable response rate. Investigators noted a median duration of response among those who responded was 22.8 months.

FDA approved the indication under accelerated approval based on the high response rate. However, continued approval may be contingent on results from a confirmatory trial. 

IV-based Lunsumio can be administered in an outpatient setting. 

Genentech notes that the drug will be available in the U.S. in the coming weeks. 

“This additional treatment option is good news for people whose blood cancer has not responded to multiple lines of treatment because it can become more difficult to treat each time it returns,” said Dr. Lee Greenberger, chief scientific officer of the Leukemia & Lymphoma Society, in a news release. “This bispecific antibody is an off-the-shelf, accessible treatment option that has the potential to help those with relapsed or refractory follicular lymphoma achieve remission.”

Bispecific antibodies are continuing to gain traction in oncology. In October, FDA approved Janssen’s Tecvayli (teclistamab) as a fifth-line treatment for multiple myeloma. The agency has also approved Amgen’s Blincyto (blinatumomab) for acute lymphoblastic leukemia, Janssen’s Rybrevant (amivantamab-vmjw) for non-small cell lung cancer and Immunocore’s Kimmtrak (tebentafusp-tebn) for uveal melanoma.”