Columvi

Generic name: glofitamab-gxbm
Dosage form: intravenous infusion
Drug class: Bispecific T-cell engagers (BiTE)

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 16, 2023.

What is Columvi?

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.

Warnings

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.

Before taking this medicine

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.

How is Columvi administered?

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.

How does Columvi work?

Columvi (glofitamab-gxbm) is a type of monoclonal antibody that is bispecific – this means it binds to two targets on different cells. It sticks to the CD20 protein on B cells (these are cancerous in B-cell lymphomas) and to the CD3 protein on T cells (these are cells of our immune system that help kill cancer cells).

This recruits the T cells directly to the tumor cells, and their proximity boosts the effectiveness of the T cells at killing the cancer cells.

What are the side effects of Columvi?

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.

Related/similar drugs

What happens if I miss a dose?

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

What other drugs will affect Columvi?

Columvi causes the release of cytokines that may suppress the activity of CYP enzymes, resulting in higher concentrations of the many other medications that are broken down by these enzymes.

This is most likely to happen after the first dose of Columvi on Cycle 1 and up to 14 days after the first 30 mg dose on Cycle 2. It can also happen during and after CRS.

Tell your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Ingredients

Columvi injection is available in two strengths:

• Glofitamab-gxbm 2.5 mg/2.5 mL (1 mg/mL) in a single-dose vial
• Glofitamab-gxbm 10 mg/10 mL (1 mg/mL) in a single-dose vial.

The injection is preservative-free and should be colorless and clear.

Manufacturer

Genentech, Inc.

Columvi Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Columvi.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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