What is Darzalex used for?
Apr 08, 2022 · Darzalex is considered an effective treatment for patients with multiple myeloma (MM) and demonstrates rapid and long-lasting responses, extending a person with MM's life expectancy. Trials report: The addition of Darzalex to regimens containing other agents (for example Revlimid/dexamethasone) was associated with a 44% reduction in the risk of disease …
How effective is Revlimid for multiple myeloma?
Aug 25, 2021 · Darzalex treats multiple myeloma by finding and binding (attaching) to multiple myeloma cells (abnormal plasma cells). When Darzalex binds to these cancerous cells, it sends a signal that causes...
How effective is acyclovir for multiple myeloma?
Aug 24, 2021 · Darzalex (daratumumab) is a highly effective drug used to treat multiple myeloma. Read about who is a candidate, side effects, special warnings. Darzalex is the first FDA-approved monoclonal antibody that targets the CD38 protein on the surface of myeloma cells.
Is Darzalex faspro a chemo?
May 05, 2021 · Dr. Joseph Mikhael: Darzalex Faspro is a very effective drug. We've seen it used as a single agent by itself and in combination. The first thing to note is that it has paralleled the response rate and the efficacy that we've seen with the IV formulation. Voiceover: Not only have studies shown Darzalex to be effective, but safe as well. Janet and Jim can't believe the …
How effective is Darzalex?
Adding Darzalex to Kyprolis and dexamethasone improved response rates from 75% to 84% and the rate of minimal residual disease was nearly 10-times higher in the three drugs group compared with the two-drug group.Apr 8, 2022
What is the success rate of daratumumab?
Daratumumab, Lenalidomide, and Dexamethasone The overall response rate was 81%, with 34% of patients achieving a complete response or better and 63% achieving a very good partial response (VGPR) or better. The median response duration was not reached, and 91% of patients were free of disease progression at 12 months.
How long does it take Darzalex to work?
In clinical studies, the average time it took Darzalex to start working was 1 month. However, you may be given your doses over a longer period of time. This depends on how your body responds to Darzalex and if your multiple myeloma starts to get worse.
What is the most effective treatment for myeloma?
Radiation therapy, which uses high-energy particles or rays to damage cancer cells and prevent them from growing, is proven to effectively treat multiple myeloma in specific situations and/or reduce complications from bone disease. Radiation therapy may also be called radiotherapy, X-ray therapy, or irradiation.
What are the side effects of Daratumumab?
AdvertisementBloating or swelling of the face, arms, hands, lower legs, or feet.chest pain or tightness.facial swelling.headache.puffiness or swelling of the eyelids or around the eyes, lips, or tongue.rapid, shallow breathing.skin rash, hives, or itching.slow or fast heartbeat.More items...•Mar 1, 2022
When do you use Darzalex?
What is DARZALEX® used for?Newly diagnosed with multiple myeloma. If you're newly diagnosed and cannot receive a stem cell transplant that uses your own stem cells (autologous stem cell transplant): ... One prior multiple myeloma treatment. ... Two prior multiple myeloma treatments. ... Three prior multiple myeloma treatments.
How long does Darzalex stay in your system?
DARZALEX® can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after your final dose of DARZALEX®.
Does Darzalex cause neuropathy?
Darzalex can sometimes cause a side effect called peripheral sensory neuropathy. This is nerve damage that causes tingling or burning sensations, numbness, or pain in your hands or feet. In studies of Darzalex, peripheral sensory neuropathy was one of the more commonly reported side effects.Aug 25, 2021
Does Darzalex cause fatigue?
The most common side effects of DARZALEX® include tiredness; nausea; diarrhea; shortness of breath; feeling weak; fever; cough; cold-like symptoms (upper respiratory infection); nerve damage causing tingling, numbness, or pain; swollen hands, ankles, or feet; constipation.
Is multiple myeloma a death sentence?
Today, a multiple myeloma diagnosis is no longer a death sentence because our community's efforts have helped bring 11 new drugs through FDA-approval.Sep 13, 2019
What is the newest treatment for multiple myeloma?
Selinexor (Xpovio) is a new type of multiple myeloma drug called a selective inhibitor of nuclear export (SINE). The FDA approved it for treatment of relapsed or refractory disease in July 2019. It's combined with dexamethasone and is used to treat people who've tried at least four previous therapies.Oct 15, 2020
What is the longest survival rate for myeloma?
A single tumor, called a solitary plasmacytoma, is present in or outside the bone. According to SEER , the 5-year survival rate for this stage is 77.5 percent....What are the 5-year survival rates for multiple myeloma?Year5-year survival rate199833.9%200239.5%200645.1%201248.5%5 more rows
Darzalex vs. Darzalex Faspro
Darzalex and Darzalex Faspro both contain daratumumab. But Darzalex Faspro also contains hyaluronidase-fihj. And while both are used to treat certain types of multiple myeloma, Darzalex Faspro is also used to treat light chain amyloidosis. This article focuses on Darzalex.
Is Darzalex considered a first-line treatment for multiple myeloma?
It depends. For some people, Darzalex may be a first-line treatment for multiple myeloma.
Is Darzalex a cure for multiple myeloma?
No, Darzalex isn’t a cure for multiple myeloma. Currently, there isn’t a cure for this condition. But Darzalex has been shown to help people with multiple myeloma live longer and improve their quality of life.
Dosage
For treating multiple myeloma, Darzalex dosing is calculated using body weight. For most of its uses, the recommended dose is 16 milligrams (mg) per kilogram (kg) of body weight. (One kilogram is about 2.2 pounds [lb].)
How to use
Darzalex comes as a liquid solution you receive by IV infusion. An infusion is an injection into your vein given over a period of time.
How often to use
How often you receive a Darzalex dose depends on the type of multiple myeloma you have. But Darzalex’s dosing schedule typically starts with more frequent infusions. And Darzalex may be given with other drugs, again depending on the type of multiple myeloma.
Symptoms of multiple myeloma
Some people with multiple myeloma don’t have any symptoms, especially early on. But others can develop symptoms, such as:
What is Darzalex approved for?
In the US, Darzalex is FDA-approved for the treatment of adult patients with myeloma in the following settings: 1 In newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT), in combination with Velcade® (bortezomib), thalidomide, and dexamethasone (VTd). 2 In newly diagnosed patients who are ineligible for ASCT, in combination with Revlimid® (lenalidomide) and dexamethasone (Rd), or Velcade, melphalan, and prednisone (VMP). 3 In patients who have received at least one prior therapy, in combination with Velcade and dexamethasone (Vd). 4 In patients with relapsed or refractory myeloma who have received one to three previous lines of therapy, in combination with Kyprolis® (carfilzomib) and dexamethasone (Kd). 5 In patients who have received at least two prior therapies including Revlimid + a proteasome inhibitor (Kyprolis, Ninlaro® [ixazomib], or Velcade), in combination with Pomalyst® (pomalidomide) and dexamethasone (Pd). 6 As monotherapy in patients who have received at least three prior lines of therapy, including a proteasome inhibitor + an immunomodulatory drug (Pomalyst, Revlimid, or thalidomide), or who are double-refractory to a proteasome inhibitor and an immunomodulatory drug.
How long does it take to take Darzalex?
The first dose is usually given over a period of up to 8 hours. Especially with the first dose, the slower the rate of infusion, the less likely it is that a severe infusion reaction will occur.
What is a proteasome inhibitor?
As monotherapy in patients who have received at least three prior lines of therapy, including a proteasome inhibitor + an immunomodulatory drug (Pomalyst, Revlimid, or thalidomide), or who are double-refractory to a proteasome inhibitor and an immunomodulatory drug.
How to contact Janssen Carepath?
Janssen CarePath Program. Please call 1-844-553-2792 or visit darzalex.com for more information. For information about the new formulation of Darzalex for subcutaneous (under the skin) administration, visit DARZALEX FASPRO™ .
What is Darzalex Faspro?
Voiceover: Darzalex Faspro is an immunotherapy. That means it sends signals to the patient's immune system to directly kill multiple myeloma cells. Dr. Joseph Mikhael: Darzalex Faspro is the subcutaneous version of the drug we have been using for many years: Darzalex, also known as daratumumab.
How many people are diagnosed with blood cancer?
More than 160,000 Americans are currently diagnosed with this disease. Dr. Joseph Mikhael: We call it blood cancer because the cancerous cell begins in the bone marrow, which is the factory of our blood. It's a special cell called a plasma cell.
When was Darzalex approved?
In August 2020 the FDA approved Darzalex® in combination with Kyprolis® (carfilzomib) and dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy.
What is Darzalex used for?
Food and Drug Administration (FDA) has approved the precision cancer medicine Darzalex (daratumumab) to treat patients with multiple myeloma as part of initial therapy or for recurrent disease . Darzalex is the first monoclonal antibody approved for treating multiple myeloma and is typically administered in combination other anti-myeloma ...
How many people in the US have multiple myeloma?
In the U.S., approximately 70,000 people are living with multiple myeloma and approximately 24,000 new individuals are diagnosed annually.
What is the phase 3 of MAIA?
The Phase III MAIA clinical study enrolled 737 newly diagnosed patients with multiple myeloma who were not candidates for high dose chemotherapy and ASCT to receive treatment with Revlimid (lenalidomide) and dexamethasone with or without Darzalex and directly compared.
Does Darzalex reduce the progression of multiple myeloma?
Darzalex plus VMP reduces disease progression or death by 50%, among patients with newly diagnosed multiple myeloma who are not eligible to undergo a stem cell transplant.Researchers have reported the results of a clinical trial designed to evaluate the addition of Darzalex™ to VMP among patients who had not yet received prior treatment, and were not eligible for a stem cell transplant. Patients in the trial were at least 65 years of age and were divided into two groups: one group was treated with Darzalex™ plus VMP (D-VMP), and the other group was treated with VMP only. Data was retrieved at a median follow-up of 16.5 months following initiation of treatment.
What is the phase 2 trial of GRIFFIN?
A phase 2 clinical trial referred to as “GRIFFIN” has demonstrated that the addition of Darzalex® to Velcade (bortezomib), Revlimid and dexamethasone (VRd) induces high response rates in newly diagnosed patients with multiple myeloma who were eligible for high-dose therapy and autologous stem cell transplantation (ASCT) compared with V Rd alone.
Can Darzalex be used with Kyprolis?
Adding Darzalex to Kyprolis and dexa methasone can significantly improve survival of relapsed or refractory multiple myeloma patients, suggesting that this three-drug combination may be an effective new regimen for this patient population, including those who were previously treated with Revlimid. (9,10)