Roche’s Genentech subsidiary has announced that the United States Food and Drug Administration (FDA) approved their CD20 and CD3 bispecific antibody, Lunsumio VELO (mosunetuzumab-axgb) subcutaneous (SC) injection to treat patients with follicular lymphoma (FL) that has relapsed or become refractory, after at least two prior lines of systemic therapy, based on efficacy results from the Phase I/II study, named GO29781. “Because patients with follicular lymphoma generally need to be treated for a lifetime, it’s essential to simplify their lives as much as possible,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “With this approval, patients can now be treated in only one minute, substantially shortening the time patients must spend at the hospital and, importantly, realigning therapy with their personal needs and values.” This accelerated approval came as a result of compelling evidence that Lunsumio VELO showed a remarkable objective response rate and complete response rate in patients with third-line or later follicular lymphoma, while dramatically shortening the treatment time to only one minute, compared to the usual 2- to 4-hour IV infusions in the past. Not to mention that, unlike ongoing treat-to-progression therapy, Lunsumio VELO’s treatment course will last no longer than six months. Of note, this provides patients with additional convenience because they could receive this treatment as outpatients, as opposed to continuous regimens that require lifetime management. “This approval represents an important start to expanding therapy options for patients living with follicular lymphoma,” said Dr. Ian Flinn, M.D., Ph.D., of Tennessee Oncology and One Oncology. “By making treatment easier to tolerate, with manageable cytokine release syndrome and short administration time, Lunsumio VELO allows me to treat my patients aggressively within a local setting.”
Also Read: Chai Discovery Secures $130M Series B to Accelerate AI-Driven Molecular Discovery
The primary outcome assessment of the GO29781 trial showed significant clinical benefit for Lunsumio VELO, indicating its promising role in a situation where few alternatives exist, although it is expected that the disease would progressively be refractory with each relapse. However, the ready use of this drug, being administered subcutaneously, is not only easier because the drug is delivered within one minute, but it has retained its promised benefits for the treatment of this hematological oncology disorder. With this approval, Genentech continues its development of its bispecific antibody range, exploring other indications that would cover the unmet demands of patients suffering from B-cell non-Hodgkin lymphoma.