Zepzelca Approved For Second-Line Treatment Of SCLC

The United States Food and Drug Administration (US FDA) has approved Zepzelca for the treatment of small cell lung cancer (SCLC). Zepzelca (lurbinectedin) is specifically used for adults whose cancer has progressed while on or after taking platinum-based chemotherapy. This means Zepzelca is a second-line treatment for SCLC. It is used for SCLC that has metastasized (spread) to other parts of the body.

Zepzelca was granted accelerated approval by the US FDA after results from a clinical trial were positive. However, more clinical trials will be needed to further strengthen the benefits of the drug. Zepzelca is the first second-line treatment for SCLC approved in almost 25 years.

How does Zepzelca work?

Zepzelca belongs to a class of drugs called alkylating agents. These kinds of drugs get into cancer cells and impact their DNA. Alkylating agents damage DNA and cause cells, including cancer cells, to die. This can help reduce tumor size or spread. However, these drugs can also cause normal, healthy cells to die as well. This is what causes many of the side effects of these kinds of drugs.

Zepzelca in clinical trials

Zepzelca was tested in a clinical trial that involved over 100 people with SCLC. All of these participants had cancer that progressed after platinum-based chemotherapy. Over a third of all participants responded to Zepzelca and the median response duration was 5.3 months. These results suggest that Zepzelca may be beneficial as a second-line treatment option. The results were promising enough that the FDA granted the drug accelerated approval in order to get it on the market sooner.

What are the side effects of Zepzelca?

Some of the most common side effects of Zepzelca include:

• Nausea, vomiting, or decreased appetite
• Constipation or diarrhea
• Cough
• Muscle or joint pain
• Low white and red blood cell counts
• Tiredness
• Trouble breathing or cough
• Changes in liver or kidney function tests
• Changes in the levels of sugar, protein, sodium, or magnesium in the blood

This is not a complete list of all possible side effects of Zepzelca. Ask your doctor for more information.

Things to know about Zepzelca

Zepzelca can lower the levels of red and white blood cells in the body. This can impact the body’s ability to fight infections. These infections can be severe. Zepzelca can also lower the number of platelets in the body. These are involved in the body’s ability to stop bleeding. Contact your doctor immediately if you have signs of an infection or bleeding. These include fever, chills, tiredness, pale skin, and unusual bleeding or bruising.

Zepzelca may impact a person’s liver function. Contact your doctor if you notice any signs of changes in liver function, including loss of appetite, nausea, vomiting, yellowing of the skin or eyes, dark urine, or pain in the upper right side of your stomach area.

Some drugs, vitamins, and supplements may impact the way Zepzelca works. Tell your doctor about any other drugs you are taking, including over-the-counter options. Some people may need to take additional drugs alongside Zepzelca. Your doctor will let you know if this is needed in your case.

Zepzelca may harm an unborn baby and could potentially pass through breast milk. Because of this, effective birth control methods are needed for females and males taking the drug. Birth control will be needed for some time after the drug has been stopped as well. Women may be required to take a pregnancy test before starting the drug. Additionally, women taking Zepzelca are advised not to breastfeed. Your doctor can help you and your partner understand what is needed if one of you could become pregnant.

Read the prescribing information to learn more about Zepzelca.^1,2