FDA Approves Cosela™ (trilaciclib) to Reduce Bone Marrow Suppression Caused by Chemotherapy

The U.S. Food and Drug Administration (FDA) has approved Coselsa (trilaciclib) to protect bone marrow from damage caused by chemotherapy. Coselsa is approved for use in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer (ES-SCLC). Extensive-stage means the cancer has spread beyond the lungs.¹

This approval makes Cosela the first drug in its class to reduce bone marrow suppression caused by chemotherapy. While Cosela is currently approved for SCLC, it is being studied for use with other types of cancer.^1,5

What is bone marrow suppression?

Chemotherapy drugs help fight cancer by killing cancer cells. However, they can sometimes also damage healthy cells. Bone marrow suppression, which is also called myelosuppression, can happen when bone marrow cells are damaged by chemotherapy.²

Bone marrow has many important jobs. It makes white blood cells, red blood cells, and platelets. These cells fight infection, transport oxygen, and stop bleeding. When the bone marrow is damaged, it makes fewer of these cells, which can lead to complications.¹

A low white blood cell count can increase the risk of infection. A low red blood cell count can cause fatigue, dizziness, or shortness of breath. A low platelet count can cause bleeding, easy bruising, or blood in urine or bowel movements. These complications can impact quality of life. If they are severe enough, doctors may have to reduce chemotherapy treatment.²

How does Cosela work?

Previously, the approach to treating bone marrow suppression was to address symptoms after the fact. Cosela may proactively protect cells in the bone marrow from the effects of chemotherapy. Cosela is a type of drug known as a kinase inhibitor. Specifically, it inhibits 2 kinases (activating sites) that impact the growth of bone marrow cells.⁴

Evidence for Cosela

Cosela was approved based on results from a clinical trial. Researchers studied 123 people on Cosela and a control group of 119 people who received a placebo (inactive pill) instead. All study participants had ES-SCLC and were being treated with chemotherapy.⁵

The results showed that the group on Cosela had a lower chance of certain complications from bone marrow suppression. The people in the Cosela group were about half as likely to have a very low white blood cell count as compared to the control group. The people in the control group were about 3 times more likely to have to reduce their chemotherapy dose because of complications from bone marrow suppression.⁵

What are the possible side effects of Cosela?

The most common side effects of Cosela include:¹

• Tiredness
• Low levels of calcium, potassium, or phosphate
• Headache
• Lung infection (pneumonia)

Some people taking Cosela may also have reactions at the injection site, including inflammation or blood clots in the veins. Cosela may also cause allergic reactions in some people, including:⁴

• Swelling of the face, eye, and tongue
• Red, itchy welts
• Analphalaxis

Your doctor will montior you for signs of reactions while taking Cosela.⁴

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

Things to know about Cosela

Cosela can harm an unborn baby. Women who can become pregnant should use birth control during treatment and for some time after the last dose of Cosela. Women should also not breastfeed during treatment with Cosela and for some time after the last dose. Talk to your doctor about your options for birth control and breastfeeding while taking Cosela.

Before beginning treatment for lung cancer, 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 Cosela.