Roche’s Subcutaneous Lunsumio Velo Receives FDA Approval for Follicular Lymphoma

The FDA has granted accelerated approval to Lunsumio Velo (mosunetuzumab) for adult patients with relapsed or refractory (R/R) follicular lymphoma who have previously received two or more lines of systemic therapy.

Follicular lymphoma, the most common indolent form of non-Hodgkin lymphoma, typically responds well to initial treatment but becomes progressively harder to treat with each relapse. Until now, many patients with R/R disease have had limited options after standard therapies fail.

Lunsumio Velo, a subcutaneous formulation of the bispecific CD20-CD3 antibody, offers a dramatic reduction in administration time. Whereas traditional intravenous (IV) formulations require two to four hours, the subcutaneous version can be delivered in approximately one minute, streamlining care and significantly reducing the treatment burden on patients and clinics alike.

The one-minute injection not only shortens time in the clinic but also supports outpatient administration, making it an attractive option for individuals whose lifestyles and clinical needs call for more flexible treatment schedules.

The FDA’s decision was supported by results from the GO29781 Phase I/II study, which evaluated Lunsumio Velo in patients with third-line or later follicular lymphoma.

In the trial, the objective response rate (ORR) was 75%, complete response rate (CRR) reached 59% and median duration of response (DOR) was 22.4 months.

“Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” Roche’s head of global product development and chief medical officer, Levi Garraway, MD, PhD, said in a press release. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.”

Lunsumio was approved in December 2022 as the first FDA-approved anti-CD20 bispecific antibody, securing approval for third-line follicular lymphoma. As an off-the-shelf IV therapy, it initially offered a clear convenience advantage over personalized CAR-T treatments.

That edge, however, was quickly challenged by AbbVie and Genmab’s competing T-cell engager Epkinly (epcoritamab), which entered the market as a subcutaneous injection. Epkinly was first approved for third-line diffuse large B-cell lymphoma (DLBCL) and later expanded into follicular lymphoma in June 2024.

With the introduction of Lunsumio Velo, Roche is now reclaiming lost ground in the alternative, more convenient administration arena.

The company is also emphasizing Lunsumio’s fixed-duration regimen, which allows patients to discontinue treatment after a defined number of cycles, an important distinction from Epkinly, which is administered continuously until disease progression or unacceptable toxicity.

The FDA’s accelerated approval means full approval will depend on confirmatory trials.

Subcutaneous versions of IV therapies have become an increasingly common strategy for drugmakers. Roche alone secured FDA approvals last year for subcutaneous versions of Tecentriq (atezolizumab) and Ocrevus (ocrelizumab), while Merck’s subcutaneous Keytruda (pembrolizumab) and Johnson & Johnson’s Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) have also recently won FDA approval.

Roche is also exploring combinations for Lunsumio Velo, including in an ongoing Phase III study investigating its use with Bristol Myers Squibb’s Revlimid (lenalidomide) in earlier lines of treatment and in combination with other targeted therapies.

Recent trial results of Lunsumio with Roche’s Polivy (polatuzumab vedotinin) in second-line large B-cell lymphoma (LBCL) patients not eligible for transplant significantly reduced the risk of progression or death by 59% compared to the traditional R-GemOx regimen.