Zynlonta Granted Accelerated Approval for Large B-Cell Lymphoma

The U.S. Food and Drug Administration (FDA) has granted ZynlontaTM (loncastuximab tesirine-lpyl) accelerated approval to treat large B-cell lymphoma.1

Zynlonta can be used in adults with large B-cell lymphoma that has relapsed (come back) or has not responded to treatment (refractory) after 2 or more treatments. This includes:1

  • Diffuse large B-cell lymphoma (DLBCL) not otherwise specified
  • DLBCL from low-grade lymphoma
  • High-grade B-cell lymphoma

The FDA may give accelerated approval to new drugs that treat a health condition with few or no other treatments. This means drugs like Zynlota can be made available sooner. A trial (or trials) will be done to confirm Zynlonta’s benefit. Zynlonta also received:1-3

  • Priority review – The FDA may give accelerated approval to new drugs that treat a health condition with few or no other treatments.
  • Orphan drug designation – An orphan drug treats, prevents, or diagnoses an orphan disease. An orphan disease is a very rare condition that is serious or life-threatening.

What are the ingredients in Zynlonta?

The active ingredient in Zynlonta is loncastuximab tesirine-lpyl.1

How does Zynlonta work?

Zynlonta is an antibody-drug conjugate (ADC). It targets CD19, which is a protein found on the surface of B-cell tumors. The antibody part of Zynlonta sticks to CD19 proteins and kills cancer cells.4

Evidence for Zynlontah

Zynlonta was approved based on a study called Lotis-2. The study was an open-label trial. This means that both the researchers and the study participants knew what drug was given. The study was also a single-arm trial. This means every person in the study received Zynlonta. No one received a placebo (inactive medicine).1,4

The study included 145 people with relapsed or refractory DLBCL or high-grade B-cell lymphoma. They also had been previously treated with at least 2 regimens. People in the study were treated with Zynlonta until disease worsened or side effects were not tolerable.1,4

Results show that 48.3 percent of people in the study had an overall response rate of 48.3 percent. This means their cancer shrank or disappeared after treatment with Zynlonta. The average length of this response was 10.3 months.1,4

What are the possible side effects of Zynlonta?

The most common side effects of Zynlonta include:1,4

  • High blood sugar
  • Feeling tired or weak
  • Rash
  • Swelling
  • Nausea
  • Muscle or joint pain

Zynlonta may also cause serious side effects, including:4

  • Fluid retention
  • Low blood cell counts
  • Infections
  • Skin reactions

These are not all the possible side effects of Zynlonta. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Zynlonta.

Things to know about Zynlonta

Avoid or limit exposure to sunlight while taking Zynlonta. Sunlight exposure can cause rash and sunburns. Avoid tanning beds and sunlight through glass, such as through car windows. If you are out in the sun, use sunscreen. Wear clothing that covers your skin.4

Zynlonta may cause fluid retention, which can be serious. Tell your doctor if you have swelling, weight gain, chest pain, difficulty breathing, or shortness of breath.4

Zynlonta may cause low blood cell counts, including platelets and red and white blood cells. Your doctor will monitor your blood counts. Tell your doctor if you have a fever or any bruising or bleeding.4

Serious infections can occur. Tell your doctor if you have a skin reaction, sun sensitivity, skin rash, peeling, or red or irritated skin.4

Zynlonta can harm an unborn baby. If you or your partner can become pregnant, you should use birth control during treatment and for some time after the last dose of Zynlonta. You should also not breastfeed during treatment with Zynlonta and for some time after the last dose. Talk to your doctor about your options for birth control and breastfeeding while taking Zynlonta.4

Before beginning treatment with Zynlonta, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Zynlonta.

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