On December 22, 2022, the FDA approved Lunsumio (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Lunsumio is the first CD20xCD3 T-cell engaging bispecific antibody, a new class of cancer immunotherapy, approved by the FDA.
T-cell engaging bispecific antibodies might address the challenges facing people with blood cancer.
Non-Hodgkin’s lymphoma, or NHL, is a disease in which malignant (cancerous) cells form in the lymph system, which is part of the immune system. It is one of the most common blood cancers among adults in the U.S.
What is the most important information I should know about LUNSUMIO?
LUNSUMIO may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO and can also be severe or life-threatening.
Get medical help right away if you develop any signs or symptoms of CRS at any time, including:
Due to the risk of CRS, you will receive LUNSUMIO on a “step-up dosing schedule.”
Your healthcare provider will check you for CRS during treatment with LUNSUMIO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with LUNSUMIO, if you have severe side effects.
What are the possible side effects of LUNSUMIO?
LUNSUMIO may cause serious side effects, including:
Your healthcare provider may temporarily stop or permanently stop treatment with LUNSUMIO if you develop severe side effects.
The most common side effects of LUNSUMIO include:tiredness, rash, fever, and headache.
The most common severe abnormal lab test results with LUNSUMIO include: decreased phosphate, increased glucose, and increased uric acid levels.
Before receiving LUNSUMIO, tell your healthcare provider about all of your medical conditions, including if you:
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while receiving LUNSUMIO?
Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.
These are not all the possible side effects of LUNSUMIO. Talk to your health care provider for more information about the benefits and risks of LUNSUMIO.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see Important Safety Information, including Serious Side Effects, as well as the LUNSUMIO full Prescribing Information and Medication Guide.
“Despite treatment advances, follicular lymphoma remains incurable and relapse is common, with outcomes worsening following each consecutive treatment,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Lunsumio represents our first approved T-cell engaging bispecific antibody and builds on our legacy of more than 20 years of innovation in blood cancer."