What Is Darzalex Faspro, and Why Does It Matter?
Darzalex Faspro is a medicine used to treat adults with multiple myeloma, a type of blood cancer, and amyloidosis, a rare condition where abnormal proteins build up in organs. It’s also the first treatment approved by the FDA for high-risk smoldering multiple myeloma, a condition that can lead to active cancer but previously had no approved therapies.
This medicine combines two ingredients: daratumumab, which is a type of antibody that targets a protein called CD38 found on certain cancer and immune cells, and hyaluronidase, an enzyme that helps the medicine absorb more easily under the skin. By attaching to CD38, daratumumab helps your immune system find and destroy cancer cells.
One of the key benefits of Darzalex Faspro is how it’s given. Instead of a long IV infusion, it’s injected subcutaneously (under the skin) — usually in the abdomen area — and takes only a few minutes. This makes treatment faster and more convenient.
The approval for high-risk smoldering multiple myeloma is especially important. In the past, you might have had to wait until the disease became active before starting treatment. Now, early use of Darzalex Faspro may help delay or even prevent the cancer from progressing. In studies, many people with this condition had signs that made them more likely to develop active cancer, such as high levels of abnormal proteins or a large number of plasma cells in the bone marrow.
Why Was It Approved?
Darzalex Faspro was approved because it showed strong results in studies for both active and high-risk smoldering multiple myeloma. In people with high-risk smoldering disease, it helped delay the time before the cancer became active. Compared to those who were only monitored, those who received Darzalex Faspro had a 51% lower chance of their disease getting worse or dying during the study period. After five years, 63% of people who got the medicine had not progressed, compared to 41% in the group that was only monitored.
For active multiple myeloma, Darzalex Faspro improved how well people responded to treatment and helped them live longer. It can be used alone or with other cancer treatments. It’s also approved for people who are newly diagnosed or whose cancer has come back, whether or not they are eligible for a stem cell transplant.
What Do I Need to Know?
Darzalex Faspro is given as a quick injection under the skin, usually in the abdomen area. It takes about three to five minutes.
The dosing schedule depends on your condition. For high-risk smoldering multiple myeloma, you’ll start with weekly injections, then move to every other week, and eventually once a month. This can continue for up to three years or until your disease gets worse.
Before each dose, you’ll get medicines like acetaminophen, antihistamines, and corticosteroids to help prevent allergic reactions. You should not use Darzalex Faspro if you’ve had a serious allergic reaction to any of its ingredients.
Like all cancer treatments, Darzalex Faspro can cause side effects. In the study for high-risk smoldering multiple myeloma, the most common side effects were upper respiratory tract infections, muscle pain, feeling tired, diarrhea, rash, trouble sleeping, numbness, and reactions at the injection site.
Darzalex Faspro may also cause hepatitis B to become active again if you’ve had it in the past. Your health care provider may test you for hepatitis B before starting treatment.
If you’re pregnant or planning to become pregnant, talk to your health care provider. This medicine may harm a fetus.