FDA Approves Genentech’s First-in-Class Medicine for Relapsed/Refractory Follicular Lymphoma After at Least Two Prior Therapies

December 22nd, 2022

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.

News in brief

• Lunsumio is the first ever CD20xCD3 T-cell engaging bispecific antibody approved by the FDA.
• Lunsumio is a chemotherapy-free, fixed-duration treatment that may be accessed in an outpatient setting.
• The approval is based on positive results from the pivotal Phase II study, which demonstrated a high and durable response rate, with 80% of patients who received at least two prior rounds of therapy achieving an overall response.
• Follicular lymphoma is the most common slow-growing form of non-Hodgkin’s lymphoma, accounting for about one in five cases.

Supporting Information

Important Safety Information

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:

• fever of 100.4°F (38°C) or higher
• chills
• low blood pressure
• fast or irregular heartbeat
• tiredness or weakness
• difficulty breathing
• headache
• confusion
• feeling anxious
• dizziness or light-headedness
• nausea
• vomiting

Due to the risk of CRS, you will receive LUNSUMIO on a “step-up dosing schedule.”

• The step-up dosing schedule is when you receive smaller “step-up” doses of LUNSUMIO on Day 1 and Day 8 of your first cycle of treatment
• You will receive a higher dose of LUNSUMIO on Day 15 of your first cycle of treatment
• If your dose of LUNSUMIO is delayed for any reason, you may need to repeat the step-up dosing schedule
• Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS

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:

• Neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with LUNSUMIO, including:
• headache
• numbness and tingling of the arms, legs, hands, or feet
• dizziness
• confusion and disorientation
• difficulty paying attention or understanding things
• forgetting things or forgetting who or where you are
• trouble speaking, reading, or writing
• sleepiness or trouble sleeping
• tremors
• loss of consciousness
• seizures
• muscle problems or muscle weakness
• loss of balance or trouble walking
• Serious infections. LUNSUMIO can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with LUNSUMIO, including:
• fever of 100.4°F (38°C) or higher
• cough
• chest pain
• tiredness
• shortness of breath
• painful rash
• sore throat
• pain during urination
• feeling weak or generally unwell
• Low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO and can also be severe. Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO. LUNSUMIO may cause the following low blood cell counts:
• low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection
• low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath
• low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems
• Growth in your tumor or worsening of tumor related problems (Tumor flare). LUNSUMIO may cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with LUNSUMIO: tender or swollen lymph nodes, chest pain, cough, trouble breathing, and pain or swelling at the site of the tumor

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:

• have ever had an infusion reaction after receiving LUNSUMIO
• have an infection, or have had an infection in the past which lasted a long time or keeps coming back
• have or have had Epstein-Barr Virus
• are pregnant or plan to become pregnant. LUNSUMIO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LUNSUMIO
  
  Females who are able to become pregnant:
• your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO
• you should use an effective method of birth control during your treatment and for 3 months after the last dose of LUNSUMIO
• are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of LUNSUMIO

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.