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FDA Approves Darzalex Faspro For Multiple Myeloma

The United States Food and Drug Administration (US FDA) has approved Darzalex Faspro for the treatment of newly diagnosed or relapsed/refractory multiple myeloma. Darzalex Faspro (a combination of the drugs daratumumab and hyaluronidase-fihj) is given subcutaneously. This means, it is injected under the skin over a few minutes, instead of infused for hours through an IV. The risk of injection site reactions may also be lower than those for IV drugs.

Darzalex Faspro is approved on its own for people with multiple myeloma who have tried at least 3 other treatment options. Darzalex Faspro can also be used in combination with steroids and other anti-cancer drugs in people who have tried at least one other treatment option. The other anti-cancer drugs that can be used with Darzalex Faspro are lenalidomide, melphalan, and bortezomib. Darzalex Faspro can also be used in people who are newly diagnosed but are ineligible for autologous stem cell transplant. A doctor can help determine which situation you fall under, and what drugs, if any, are needed alongside Darzalex Faspro.

How does Darzalex Faspro work?

One of the active ingredients in Darzalex Faspro is called daratumumab. This drug is a monoclonal antibody. This means it is made from living cells and has a very specific target in the body. It targets a protein on the outside of some cells called CD38. Multiple myeloma cells have many of these proteins on their surface. By targeting this protein, Darzalex Faspro can help the body’s own immune system recognize and attack cancer cells.

Darzalex Faspro in clinical trials

The safety and efficacy of Darzalex Faspro were evaluated in clinical trials called the COLUMBA and PLEIADES trials. The COLUMBA trial studied Darzalex Faspro on its own. The PLEIADES trial studied Darzalex Faspro in combination with steroids and other anti-cancer drugs.

The COLUMBA trial compared Darzalex Faspro against an already available IV form of daratumumab. The response rate to the new medication was similar to, if not better than, the original IV drug. About 41 percent of participants responded to the new drug, compared to 37 percent to the older drug. In the combination trials, response rates were even higher, with 88 to 91 percent of people responding to the new drug. These response rates suggest that many people might benefit from treatment with Darzalex Faspro, and that it is safe to use.

What are the side effects of Darzalex Faspro?

The side effects of Darzalex Faspro may vary based on what other drugs are taken alongside it. The most common side effects include, but may not be limited to:

  • Upper respiratory tract infections
  • Pneumonia
  • Bowel changes, including constipation or diarrhea
  • Nausea or vomiting
  • Fatigue
  • Trouble sleeping
  • Fever
  • Numbness, tingling, or pain in the hands or feet (also called peripheral sensory neuropathy)
  • Cough or shortness of breath
  • Back pain or other muscle spasms
  • Decreased blood cells, including white blood cells and platelets
  • Decreased hemoglobin (which helps carry oxygen throughout the body)

Things to know about Darzalex Faspro

As with any treatment option, there are rare risks to taking Darzalex Faspro. Darzalex Faspro may cause low blood cell counts. This includes low white blood cells called neutrophils. Low neutrophil counts (called neutropenia) can increase a person’s risk of infection. Darzalex Faspro can also lower the amount of blood cells called platelets. This may increase a person’s risk of bleeding. Your doctor will monitor your blood cell counts while you are taking Darzalex Faspro.

Darzalex Faspro can interfere with the tests used to match blood products if you need a blood transfusion. Before starting Darzalex Faspro, your doctor will run a blood test to determine your blood type, and what blood products may be safe for you in case of an emergency.

Darzalex Faspro may harm an unborn baby. If you or your partner could become pregnant, effective birth control should be used while taking the drug. Rarely, a person may be allergic to Darzalex Faspro. If you notice signs of an allergic reaction, like face or lip swelling, trouble breathing, wheezing, or throat tightness, contact your doctor immediately.

Read the prescribing information to learn more about Darzalex Faspro.1,2

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