Headline: FDA Approves Sarclisa Escena, an Under-the-Skin Injection for Multiple Myeloma

The FDA has approved Sarclisa Escena (isatuximab-irfc) for adults with a type of bone marrow cancer called multiple myeloma. This medicine is used along with other standard cancer drugs in people who are newly diagnosed or in those whose cancer has come back after other treatments.

Before this approval, patients had to get this medicine (Sarclisa) as an infusion into a vein (IV). Sarclisa Escena is a new version of the medicine that can be given as an injection under the skin (subcutaneous). This injection can be given with a regular syringe or through a wearable device called the CirCLIQ On-Body Injector.

This medicine works by targeting a specific protein called CD38 that is found on the surface of multiple myeloma cancer cells. It attaches to these cancer cells and kills them. It also helps the body’s immune system find and destroy the cancer cells.

Why Was It Approved?

This approval was based on a clinical study of 531 adults whose multiple myeloma returned after receiving other treatments. These patients were split into two groups. One group received the new under-the-skin injection, and the other group received the older IV version. Everyone also took two other common cancer medicines.

The study wanted to see if the new injection worked as well as the IV drug. In both groups, about 71% of patients had their cancer shrink or disappear. This showed that both options are similarly effective at fighting cancer.

The study also showed that the under-the-skin injection offered benefits for patient comfort. Only 1.5% of patients who got the under-the-skin injection had whole-body reactions to the injection. In comparison, 25% of patients in the IV group had those reactions. Less than 1% of patients getting the under-the-skin injection had skin reactions where the needle went in, and these were mostly minor. Common side effects for both groups included fatigue, diarrhea, lung infections, and low blood cell counts.

What Do I Need to Know?

Sarclisa Escena is given as an injection into your stomach area by a health care provider. If they use the wearable on-body injector, it stays on your skin and takes about 20 minutes. If they use a syringe, the injection takes about six minutes. You will also get medicines before your injection to help prevent allergic reactions. The medicine is given weekly at first. After the first month, it is given every two or four weeks depending on your specific treatment plan.

The most common side effects include respiratory infections, tiredness, diarrhea, trouble sleeping, and muscle or joint pain. The drug can also lower your blood cell counts. Your doctor will check your blood often to watch for these problems. Low levels of white blood cells can increase your risk of serious infections. Tell your health care provider right away if you develop a fever or any symptoms of an infection.

This medicine can harm a fetus. Women who can get pregnant must take a pregnancy test before starting. They must use effective birth control during treatment and for seven months after their last dose. It is also important not to breastfeed during this time.

Because Sarclisa Escena is used with other medicines, there may be other serious safety concerns to consider. Speak with your health care provider about any safety concerns or rules for other cancer medicines you will receive.

Before starting this medicine, tell your doctor about all the medicines, vitamins, and supplements you take. If you need a blood transfusion, make sure to tell all your health care providers that you are taking Sarclisa Escena. This medicine can change the results of certain blood tests for up to six months after your last dose, which may affect your blood transfusion.