Columvi

Columvi is used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed), or that did not respond to previous treatment (refractory),and who have received 2 or more prior treatments for their cancer. It is administered via an IV infusion. Columvi is a prescription bispecific T-cell engager (BiTE) that works by bringing the body's T cells into close contact with cancerous B cells, helping the immune system destroy them.

Columvi (glofitamab-gxbm) received FDA approval on June 15, 2023, under the accelerated approval designation. Continued approval may be dependent upon a continued benefit being shown in clinical trials.

Approval was based on a single-arm study (NP30179) of 132 adults with relapsed or refractory DLBCL, NOS or LBCL arising from follicular lymphoma who had received 2 or more prior therapies. The overall response rate was 56%, with 43% achieving a complete response. Among those who responded, the median duration of response was 18.4 months, and an estimated 68.5% were still responding at 9 months.

There is no Columvi generic.

Columvi can cause serious side effects and carries a Boxed Warning for cytokine release syndrome.

Cytokine Release Syndrome (CRS)

Columvi can cause CRS, a serious side effect that is common during treatment and can also be serious and lead to death. Tell your healthcare provider or get medical help right away if you develop any signs orsymptoms of CRS, including:

• fever of 100.4°F (38°C) or higher
• chills or shaking
• fast or irregular heartbeat
• dizziness or light-headedness
• trouble breathing
• shortness of breath.

Due to the risk of CRS, you will receive Columvi on a "step-up dosing schedule".

• The "step-up dosing schedule" is when you receive smaller "step-up" doses of Columvi to help reduce your risk of CRS.
• You will receive a medicine called obinutuzumab on the first day of your first treatment cycle (Day 1 of Cycle 1). You will start the Columvi "step-up dosing schedule" a week after the obinutuzumab dose.
• You will receive smaller "step-up" doses of Columvi on Day 8 and Day 15 of Cycle 1.
• You will receive your first full dose of Columvi a week after the second "step-up" dose (this will be Day 1 of Cycle 2).
• Before each dose of Columvi, you will receive medicines to help reduce your risk of CRS and infusion-related reactions.
• You should be hospitalized during your infusion and for 24 hours: after receiving the first "step-up" dose on Day 8 of Cycle 1. after receiving the second "step-up dose" on Day 15 of Cycle 1, if you experienced CRS during the first "step-up" dose. if you had more than mild CRS with your previous dose of Columvi.
• If your dose of Columvi is delayed for any reason, you may need to repeat the "step-up dosing schedule".
• Your healthcare provider will monitor you for CRS during treatment with Columvi and may treat you in a hospital if you develop signs and symptoms of CRS.
• See "How will I receive Columvi?" for more information about how you will receive Columvi.
• Your healthcare provider may temporarily stop or completely stop your treatment with Columvi if you have severe side effects.
• Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Columvi Patient Wallet Card lists the signs and symptoms of CRS that you should get medical help for right away.

See below for more information about side effects.

Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection
• are pregnant or plan to become pregnant. Columvi may harm your unborn baby. Females who can become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with Columvi. Use effective birth control (contraception) during treatment and for 1 month after your last dose of Columvi. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Columvi.
• are breastfeeding or plan to breastfeed. It is not known if Columvi passes into your breastmilk. Do not breastfeed during treatment and for 1 month after your last dose of Columvi.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Common side effects

The most common side effects of Columvi are: cytokine release syndrome (CRS), muscle and bone pain, rash, and tiredness.

The most common severe abnormal blood test results with Columvi include: decreased white blood cells,decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting).

Serious side effects

See Important information above. Columvi can cause other serious side effects, such as:

• Neurologic problems. Columvi can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with Columvi. 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, including: headache confusion and disorientation difficulty paying attention or understanding things trouble speaking sleepiness memory problems numbness, tingling, or weakness of the hands or feet dizziness shaking (tremors).
• Serious infections. Columvi can cause serious infections that may lead to death, including progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal viral disease that damages the brain's white matter. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your healthcare provider right away if you develop any signs of infection, including fever, chills, weakness, loss of balance or trouble walking, vision changes, cough, shortness of breath, sore throat, difficulty speaking, or confusion.
• Growth in your tumor or worsening of tumor-related problems (tumor flare). Tell your healthcare provider if you get any of these signs or symptoms of tumor flare: tender or swollen lymph nodes pain or swelling at the site of the tumor chest pain cough trouble breathing.

Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects.

These are not all the possible side effects of Columvi. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Columvi will be given to you by your healthcare provider by infusion through a needle placed in your vein (intravenous infusion). You should be well-hydrated before receiving treatment.

Your Columvi treatment schedule is divided into cycles that are 21 days (3 weeks) long.

• On Day 1 of Cycle 1, your healthcare provider will give you a medicine called obinutuzumab by intravenous infusion.
• On Day 8 and Day 15 of Cycle 1, you will receive “step-up” doses of Columvi.
• Starting with Cycle 2, you will receive a full dose of Columvi 1 time every three weeks.

Your healthcare provider will decide how many treatment cycles you will receive of Columvi.

See also Important information above.

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems.

See Side effects above for more information about signs and symptoms of neurological problems.

Active ingredient: glofitamab-gxbmInactive ingredients: histidine, histidine hydrochloride monohydrate, methionine, polysorbate 20, sucrose, and Water for injection.

Available in two strengths:

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

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

Columvi injection is manufactured by Genentech Inc., a member of the Roche group, 1 DNA Way, South San Francisco, CA 94080-4990. U.S. License No.: 1048.