Columvi (glofitamab-gxbm) is an immunotherapy treatment that may be used to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after at least 2 lines of systemic therapy.

Large B-cell lymphoma is an aggressive type of non-Hodgkin’s lymphoma (NHL) resulting from the malignant proliferation of B cells during their various stages of development. LBCL is one of the most prevalent types of blood cancer among adults.

The approval of Columvi represents a much-needed further treatment option for B-cell lymphoma patients and was based on impressive results including a 56% overall response rate and a complete response rate of 43%. 68.5% of patients experienced a long-lasting response of 9 months or longer (median duration of response, 18.4 months).

Columvi belongs to a new class of medicines known as CD20×CD3 T-cell engaging bispecific monoclonal antibodies. It was granted accelerated approval by the FDA on June 15, 2023.

Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving Columvi.  CRS happens when there is a large release of messenger proteins (cytokines) from immune cells that have been activated by immunotherapy treatment. Symptoms can be mild to moderate such as fever, chills, nausea, headache, rash, irritated throat, nausea, and vomiting. Severe symptoms can be life-threatening and include low blood pressure, cardiovascular problems, and reduced oxygen levels.

Your doctor should provide you with a Patient Wallet Card that describes the symptoms of CRS and what to do about them.

Columvi must be administered by a healthcare professional in an appropriate facility with immediate access to medical support including supportive medications to manage cytokine release syndrome (CRS).

• Seven days before treatment with Columvi, patients should be pretreated with a single 1,000mg dose of Obinutuzumab (Gazyva) administered by intravenous infusion. This depletes circulating and lymphoid tissue B cells.
• Patients should be adequately hydrated before Columvi administration.
• Premedicate with dexamethasone IV, oral acetaminophen, and an antihistamine (such as diphenhydramine 50mg oral/IV) at least 30 minutes to 1 hour before the Columvi infusion as detailed in the product information.
• Administer Columvi as an intravenous infusion according to the step-up dosing schedule detailed in the product information. Patients should remain hospitalized during and for 24 hours post-infusion of step-up dose 1 because of the risk of CRS. The infusion is usually given over 4 hours for the first 2 cycles. This may be increased to 8 hours in those experiencing CRS.
• For subsequent doses, patients who experienced CRS of at least Grade 2 should be hospitalized for 24 hours post-infusion.

Before each dose of Columvi, you will be given premedication to reduce the risk of CRS. The step-up dosing schedule of glofitamab-gxbm outlined in the product information will also be followed. If CRS occurs, then Columvi will be withheld until it resolves or permanently discontinued depending on severity.

You will be monitored for neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which can be severe.

Columvi can cause serious or fatal infections. You will be monitored for signs and symptoms of infection and treated appropriately.

Can cause serious tumor flare reactions.

Patients at risk of tumor lysis syndrome should be adequately hydrated before treatment and administered anti-hyperuricemics.

Your doctor may prescribe antiviral prophylaxis to prevent herpes virus reactivation or to reduce the risk of cytomegalovirus. Pneumocystis jirovecii Pneumonia (PJP) prophylaxis may also be considered.

May cause fetal harm. If you are a female of reproductive potential, there is a risk to the unborn baby if you become pregnant and you must use effective contraception while being administered Columvi and for at least one month after the last dose.

Do not breastfeed while being administered Columvi.

If a dose of Columvi is missed, your doctor will restart treatment based on recommendations outlined in the product information.

The most common side effects include:

• Cytokine release syndrome (CRS)
• Musculoskeletal pain
• Rash
• Fatigue.

Other side effects include:

• Constipation
• Diarrhea
• Edema
• Fever
• Nausea
• Abdominal pain
• Tumor flare
• Headache.

May also cause Grade 3 to 4 laboratory abnormalities such as decreases in lymphocytes, phosphate, potassium, sodium, calcium, neutrophils, and fibrinogen. Uric acid levels and gamma-glutamyl transferase may increase. Anemia and thrombocytopenia can also occur.