What Is It, and Why Does It Matter?
The FDA has approved a new combination therapy for treating multiple myeloma in adults in whom the cancer has come back (relapsed) or did not respond to previous treatment (refractory). The therapy includes two medicines, Tecvayli (teclistamab) and Darzalex Faspro (daratumumab and hyaluronidase), together called Tec-Dara, and is meant for patients who have already received at least one prior treatment for multiple myeloma.
Multiple myeloma is a type of blood cancer in which abnormal plasma cells (a type of white blood cell) grow out of control. As these abnormal plasma cells crowd the bone marrow, the production of normal white blood cells, red blood cells, and platelets decreases, leading to infections, anemia, and bleeding. Multiple myeloma is the third most common blood cancer worldwide and currently has no cure. Although some patients may not show symptoms at the time of diagnosis, the common symptoms include bone pain or fractures, tiredness, low red blood cell counts (anemia), high calcium levels, kidney problems, and frequent infections. In the U.S., about 35,000 people were expected to be diagnosed in 2024, and more than 12,000 people were expected to die from the disease. About 60% of people survive five years after diagnosis.
Tecvayli is a first-in-class bispecific lab-made antibody (immunotherapy medicine) that works by helping the body's immune system find and attack myeloma cells. It connects T cells (immune cells that kill cancer cells) to the B-cell maturation antigen (BCMA) on myeloma cells, which helps the immune system destroy the cancer cells. This is effective, as many myeloma cells have high levels of BCMA protein on their surface that promotes their growth and survival. Tecvayli was first approved in 2022 for adults with relapsed or refractory multiple myeloma who had received at least four treatments.
Darzalex Faspro combines two ingredients – daratumumab and hyaluronidase. Daratumumab is a lab-made antibody that works by targeting a special protein called CD38 on myeloma cells, which helps your immune system identify, find, and destroy abnormal blood cells. Hyaluronidase works by speeding up and improving the absorption of the medicine. First approved in 2020, Darzalex Faspro is used to treat multiple myeloma or related conditions in adults, either alone or combined with various other medicines. It's also used with other medicines to treat amyloid light-chain amyloidosis.
The approval matters because combining Tecvayli with Darzalex Faspro provides a better way to activate the immune system to attack myeloma cells. Also, the Tec-Dara combination offers patients with relapsed or unresponsive multiple myeloma a new second‑line treatment option that may be given earlier in the course of illness and delivered as more convenient under-the-skin shots than intravenous (IV) therapies.
Why Was It Approved?
The FDA's decision was based on clinical studies that showed that the Tec-Dara combination is safe and effective in not only controlling myeloma but also helping patients live longer and achieve lasting responses. The clinical trial included 587 adults with relapsed or refractory multiple myeloma who had received at least one prior treatment. The patients were randomly assigned to receive Tec-Dara or daratumumab combined with dexamethasone plus pomalidomide (DPd) or bortezomib (DVd).
The trial's results showed that after three years, compared to the DPd or DVd groups, the Tec-Dara group had a significantly reduced risk of cancer progression or death (83% vs. 30%) as more patients responded to Tec-Dara than to DPd or DVd (89% vs. 75%), had a complete response (82% vs. 32%), and had no detectable cancer when checked with sensitive tests (58% vs. 17%). The overall survival at three years was 83% with Tec-Dara, compared with 65% with standard therapy.
The most common side effects when taking Tecvayli with Darzalex Faspro include low antibody levels, a higher chance of getting infections (such as COVID-19, pneumonia, or upper respiratory infections), cytokine release syndrome, coughing, diarrhea, muscle or joint pain, reactions where you get the shot (redness, heat, swelling, or bruising), fatigue, fever, headaches, nausea, stomach infections, allergic reactions, and weight loss. Common serious lab changes include low levels of white blood cells, lymphocytes, neutrophils, hemoglobin, and platelets, which can increase the risk of infections, anemia, or bleeding.
Nerve‑related side effects, including immune effector cell-associated neurotoxicity syndrome (ICANS), have occurred during trials. Neurologic effects were frequent, but deaths from these events were rare.
What Do I Need to Know?
Both medicines are given as shots under the skin, with Tecvayli given in the abdomen (belly area), thigh, or other body sites, and Darzalex Faspro given only in the abdomen. Darzalex Faspro is given first on treatment days. The dosing for Tecvayli starts with smaller "step‑up" doses before moving to full treatment doses, and Darzalex Faspro is continued weekly, then every two weeks, and later, every four weeks alongside Tecvayli to help manage the myeloma. Your health care provider will determine the exact schedule and dosing for your medicines. If you miss a dose, contact your health care provider right away to reschedule your appointment.
You need to stay in the hospital for 48 hours after each of the first two step‑up doses of Tecvayli. You will also be monitored closely for 48 hours after your first full dose. Your health care provider will give you certain medicines around these early doses to help prevent reactions.
Before starting treatment, tell your health care provider about your medical history, especially if you have or have had breathing problems, shingles, or a current/past hepatitis B infection. Darzalex Faspro can reactivate the hepatitis B virus, so your health care provider will check you before, during, and after treatment.
Darzalex Faspro can lower your blood cell counts, which may increase your risk of infections or bleeding. Your health care provider will check your blood regularly and watch for signs of infection. Some infections linked to this medicine can be life-threatening. Darzalex Faspro can also affect results of blood tests used to match blood groups/types. So if you ever need a blood transfusion, make sure all your health care providers and the blood bank know that you've received Darzalex Faspro.
Tecvayli can change how your liver processes some medicines. Tell your health care team about all prescription and over‑the‑counter medicines and supplements you take, so they can check for interactions and adjust doses if needed. While taking Tecvayli, do not drive or use heavy machinery during the step‑up dosing phase and for 48 hours afterward or until new neurologic symptoms such as dizziness, confusion, tremors, and sleepiness that you may get go away.
Tecvayli has a boxed warning for cytokine release syndrome and neurologic side effects including ICANS. Because of these risks, Tecvayli is available only through the safety program called TALVEY Risk Evaluation and Mitigation Strategy. You will also receive a patient wallet card with warning signs. Keep it with you and show it to any health care provider you see.
If you are pregnant, planning to become pregnant, or breastfeeding, avoid Darzalex Faspro and Tecvayli, as they can harm your baby. Use effective birth control during treatment and for three months after using Darzalex Faspro and five months after using Tecvayli, and do not breastfeed during treatment or for these periods afterward.
Contact your health care provider right away if you have signs of an infection such as a fever; pain while urinating; trouble breathing; a fast heartbeat; confusion or restlessness; a severe headache; new weakness; trouble speaking or remembering things; jerking movements or tremors; eye or vision problems; unusual bleeding or bruising; or signs of an allergic reaction such as breathing problems, wheezing, dizziness, or a runny or stuffy nose. These could be signs of serious side effects.