Rituximab
Rituximab is used to treat certain types of cancer.
Full Answer
How effective is Rituximab for lymphoma?
Significantly more patients in the two rituximab arms avoided chemotherapy at 3 years, leading the investigators to conclude that single-agent rituximab should be considered an option for untreated low-burden FL. Of note, almost half the patients in the watchful waiting arm had not initiated treatment for FL after 3 years.
Do I need Rituxan maintenance?
Your doctor may decide to prescribe RITUXAN as maintenance therapy if you achieve remission after using RITUXAN and chemotherapy as initial treatment. RITUXAN is prescribed alone, without chemotherapy, every 8 weeks for 12 doses during this phase of the journey. Your goal here is to help keep your disease in remission.
Is Rituxan a chemo drug?
One is evaluating the BI-1206 combination with rituximab for the treatment of Non-Hodgkin lymphoma, which includes patients with follicular lymphoma, MCL and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab.
Can lymphoma be treated without chemotherapy?
When you skip chemotherapy, you won't get symptoms like sickness, infection, and hair loss. Another benefit is your lymphoma cells won't get resistant to medicine, which is a problem for some people. When that happens, treatment may not work as well anymore. You'll also avoid hospital stays and continue to enjoy the activities that you like.
How long has RITUXAN been used?
This chimeric technology was the basis for rituximab production, and in 1997 the FDA approved rituximab, brand name Rituxan, for use to treat follicular lymphoma (FL) (7). Rituximab was created by Ronald Levy for the express purpose of targeting malignant B cells.
Is RITUXAN maintenance necessary?
Your doctor may decide to prescribe RITUXAN as maintenance therapy if you achieve remission after using RITUXAN and chemotherapy as initial treatment. RITUXAN is prescribed alone, without chemotherapy, every 8 weeks for 12 doses during this phase of the journey. Your goal here is to help keep your disease in remission.
How long can you stay on RITUXAN?
Rituxan can provide up to 6 months of symptom improvement from 1 course of treatment (2 infusions given 2 weeks apart). Be sure to talk with your doctor to find out if starting and continuing treatment with Rituxan is right for you.
When was RITUXAN approved?
Rituxan was approved in November 1997 and is manufactured by Genentech. With the Truxima approval, the FDA has approved 15 biosimiliars.
Can lymphoma come back while on maintenance?
Your cancer may stay under good control for many years. But it's always possible that it could come back in the future or change into a different type. You can think of follicular lymphoma like a chronic disease. It may come back from time to time, but there are treatments to control it.
What is maintenance treatment for lymphoma?
What is maintenance therapy? Maintenance therapy is sometimes given after initial treatment has put the lymphoma into remission (no evidence of disease). It is used to make the remission last as long as possible by suppressing any lymphoma cells that can't be detected by scans after the main treatment has finished.
What happens when you stop taking Rituxan?
Even if you have stopped taking rituximab the risk goes on for at least several months (it is unknown for exactly how long). Your doctor will discuss this risk with you and explain what testing is recommended to check for hepatitis. A mild to moderate change in blood pressure may also occur during infusion.
How many times can you have rituximab?
Administer RITUXAN as a single-agent every 8 weeks for 12 doses. Following completion of 6-8 cycles of CVP chemotherapy, administer once weekly for 4 doses at 6-month intervals to a maximum of 16 doses.
How effective is Rituxan for lymphoma?
The study results initially published in the The Lancet demonstrated that three-year progression-free survival was 75% among patients given Rituxan maintenance therapy compared with 57% of patients given no maintenance therapy suggesting that maintenance therapy with Rituxan prolonged remission among patients in a ...
When was Rituxan approved for CLL?
FDA approves rituximab plus hyaluronidase combination for Treatment of FL, DLBCL and CLL. On June 22, 2017, the U.S. Food and Drug Administration granted regular approval to the combination of rituximab and hyaluronidase human (RITUXAN HYCELA, Genentech Inc.)
Does rituximab cause immunosuppression?
Rituximab may in addition cause immunosuppression through several other mechanisms such as delayed-onset cytopenia, particularly neutropenia and hypogammaglobulinemia. Clinical trials have shown conflicting results regarding the association of rituximab with infections.
What is Rituxan made of?
Rituximab is a man-made antibody that was developed using cloning and recombinant DNA technology from human and murine (mice or rat) genes. Rituximab is thought to attach to the CD20 receptor and cause the tumor cells to disintegrate (lyse).
What is the drug used for relapsed follicular lymphoma?
Rituximab is a monoclonal antibody drug engineered to specifically attach itself to normal B cells and more than 90% of B-cell lymphomas. It was approved for use in relapsed follicular lymphoma and indolent lymphoma in 1997. In these types of lymphoma, about 48% of patients will respond to treatment, meaning the cancer will decrease or at least stop growing in response to treatment.
What type of lymphoma is 282?
Of these, 282 had follicular lymphoma, which is a common type of non-Hodgkin Lymphoma (NHL). It is a slow growing lymphoma that arises from B-cells, a type of white blood cell. All had received a combination chemotherapy regimen of cyclophosphamide, vincristine, and prednisone (CVP).
How often is rituximab administered?
A schedule of administration once per week for 4 weeks was repeated every 6 months (four courses) for 2 years. The primary measure of effectiveness for the study was the length of progression-free survival measured from completion of chemotherapy. They compared patients treated with maintenance rituximab to patients who received no further treatment following completion of chemotherapy.
What are the toxicities of rituximab?
Grade 3 infections occurred in 1% in both groups. Other grade 3 toxicities in the rituximab group included lung, heart, allergy, weight gain, and nerve problems, affecting 1% or less.
How long does it take for a B cell to deplete after taking Rituximab?
Under the approved dose and schedule of once per week for 4 weeks, often results in B-cell depletion that lasts for up to 6 months.
When was the Rituximab study designed?
Since this study was designed in 1996 before rituximab was a standard. part of initial therapy this trial cannot answer questions about the. benefit of rituximab maintenance in patients who were initially treated. with the current standard treatment using chemotherapy plus rituximab.
Does rituximab increase the length of time before cancer resumes?
The researchers in this study wanted to determine if giving rituximab over a long period to patients with advanced-stage, slow-growing (indolent) lymphoma after standard chemotherapy would increase the length of time before the cancer resumed growing (progression-free survival).
What is CD20 used for?
It may be used for cancers and noncancerous diseases. 3. Cancers: 3. People with some types of non-Hodgkin's lymphomas including follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). People with chronic lymphocytic leukemia (CLL) which is CD20 positive. Noncancerous Diseases: 3.
What is the best treatment for follicular lymphoma?
Follicular lymphoma - Follicular lymphoma is the most common type of indolent — meaning slow-growing—NHL, usually appearing in lymph nodes throughout the body. As a slow-growing type of NHL, FL does not always require immediate treatment. If your doctor decides to use Rituxan for FL, it is used in 2 different ways: 1 Initial treatment: to get to remission#N#Rituxan is used in combination with chemotherapy. If treatment results in partial or complete remission, Rituxan may be used as maintenance therapy. 2 Maintenance therapy: to stay in remission#N#The goal of maintenance therapy is to help keep the disease in remission for a longer period of time. Rituxan is used alone, without chemotherapy, during maintenance therapy. 1
What antibody is used to recognize surface markers?
The next step was to find a drug that could act like the antibodies our body's make—antibodies that would likewise recognize surface markers, but on cancer cells. Rituxan (rituximab) is the "artificial antibody" found to stick to the CD20 antigen on cancerous young pre-B cells and mature B-lymphocytes. Once Rituxan binds to the CD20 on the cancerous cells, there are likely a few mechanisms by which the cancer cells are then destroyed. 1
How is Rituxan given?
How Rituxan Is Given. Rituxan is administered as an infusion in your veins. Rituximab is given over a few hours. The infusion is started slowly, and if the patient does not show any reactions to the medicine, the rate of infusion is increased every hour until the infusion is over.
What is a DLBCL?
Diffuse large B-cell lymphoma (DLBCL) - Diffuse large B-cell lymphoma makes up more than 30 percent of newly diagnosed cases of NHL. 4 Rituxan is considered a standard part of initial treatment when used with chemotherapy combinations like CHOP. Three large studies have demonstrated that not only does adding Rituxan delay disease relapse or progression, it may also result in improved survival. Rituxan is therefore given with each cycle of chemotherapy and may be continued for a period beyond completion of chemotherapy cycles. 1 For those who have been treated earlier with chemotherapy alone and have now relapsed or progressed, Rituxan may be administered as a salvage treatment. (Salvage treatment refers to a treatment which decreases symptoms and/or extends survival, but cannot cure the disease.)
How long does Rituxan last?
Rituxan is administered on a weekly basis for 4 to 8 weeks when it is administered alone. When administered along with chemotherapy, it is usually given on the first day of each cycle of chemotherapy for each of the 6 to 8 cycles. The main side effects of Rituxan are related to infusion allergic reactions.
What are the markers of non-Hodgkin lymphoma?
It's been found that some non-Hodgkin lymphoma cells also have markers that can set them apart. This marker is called the CD20 antigen and is on the surface of some of our immune cells known as B-lymphocytes, or B cells. These are the cells that become cancerous in some forms of non-Hodgkin lymphoma and chronic lymphocytic leukemia. 2
What is PFS in medical?
PFS is a composite endpoint that counts progression, relapse, or death as one event. Notably, to our knowledge, there has been no significant difference in deaths reported in the studies that have evaluated Rituxan as maintenance compared to observation at this time (April 2013).
How often is Rituxan given?
Rituxan Maintenance (RM) is regularly-scheduled-therapy with Rituxan antibody given in weekly cycles. The Rituxan might be given every 3 or 4 months for as long as 2 years for the purpose of increasing the duration of the response to standard therapy for lymphoma, such as Rituxan-based chemotherapy.
What is the response rate to rituximab?
Overall response rate to second-line therapy 180/227 (79%) in patients from the observation arm (CR/CRu=61%; PR=19%) versus 109/144 (76%) in patients from the rituximab maintenance arm (CR/CRu =51%; PR=22%) (P=NS). I think the emphasis should be on the CR rate as I feel it's the most clinically important endpoint for subsequent therapy - but even that difference is small.
What are the most common adverse events in rituximab?
Most common adverse events reported were infections (24% and 39%) in the observation and rituximab maintenance arms respectively. Grade 3-4 adverse events were reported in 17% of patients in the observation arm and 24% in the rituximab maintenance arm (neutropenia 1% vs 4%; infections 1% vs 4%, respectively) but these lead to treatment discontinuation in only 8 and 19 patients, respectively.
Is Rituxan good for mantle cell lymphoma?
Maintenance Rituxan for Mantle Cell Lymphoma seems to be less controversial because of recent positive findings in a study. For CLL, maintenance Rituxan is not widely used. Following Rituxan monotherapy, observations appears to be as good as maintenance (based on RESORT) with less cost and toxicity.
What are the risks of maintenance R?
The risks of maintenance R (MR) include: rare but fatal PML, serious, more common but not a majority: low Ig antibodies leading to chronic infection.
What is my concern with the sponsor statement?
My concern is that the sponsor statement will be interpreted by many readers that you have a lower chance of dying with maintenance.
How long does rituximab last?
Although studies are ongoing, there are no available data regarding the safety and efficacy of treatment for more than 24 months. Many patients who benefit from maintenance rituximab and stop treatment after an arbitrary 24 months of therapy retain sensitivity to rituximab and respond again at the time of disease progression. [10] In such patients, it is reasonable to infer that continuation of maintenance rituximab beyond 24 months would have further prolonged their remission duration.
Is rituximab a monoclonal antibody?
Recent trials have demonstrated improvements in progression-free and overall survival with the inclusion of the chimeric anti-CD20 monoclonal antibody rituxim ab (Rituxan) in chemotherapy regimens for treatment-naive and relapsed patients with advanced-stage follicular non-Hodgkin's lymphoma (NHL). As rituximab therapy has significant single-agent activity in follicular NHL, is generally well tolerated, and has no dose-limiting or significant hematologic toxicity, a number of approaches evaluating maintenance therapy with extended dosing of rituximab are being tested. Trials have demonstrated prolonged progression-free survival in patients treated with maintenance rituximab using a variety of schedules following treatment with single-agent rituximab, induction or salvage chemotherapy, or salvage therapy with rituximab and chemotherapy combinations. Small increases in neutropenia and infections have been reported with extended rituximab use. Ongoing trials are evaluating the optimal use of rituximab (maintenance vs retreatment) and the benefit of rituximab maintenance following treatment of therapy-naive patients treated with rituximab-containing chemoimmunotherapy induction regimens. This article discusses the risks and benefits of maintenance rituximab for follicular NHL.
How It Works
Uses
- Rituxan is used for both cancerous and noncancerous diseases. How is this possible? Well, it all relates to the white blood cells known as B-cells or B-lymphocytes, which are part of the immune system. B-cells—the same cells that become cancerous in a variety of lymphomas—may also play a role in the development of rheumatoid arthritis and other inflammatory illnesses. It may be use…
Targeting B-Cells in Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
- The addition of Rituxan to our repertoire of drugs to treat NHL has made a significant difference. Prior to its introduction at the beginning of this century, the death rate from lymphoma had been steadily rising. Since that time it has been declining, likely due to improved survival from Rituxan. Some of the lymphomas for which Rituxan makes a dif...
How Rituxan Is Given
- Rituxan is administered as an infusion in your veins. Rituximab is given over a few hours. The infusion is started slowly, and if the patient does not show any reactions to the medicine, the rate of infusion is increased every hour until the infusion is over. Rituxan is administered on a weekly basis for 4 to 8 weeks when it is administered alone. When administered along with chemothera…
Gazyva
- As opposed to Rituxan, Gazyva is a fully humanized monoclonal antibody. Gazyva as a newer drug that targets the same "tag" as Rituxan, namely the CD20 antigen. Rituxan and Gazyva both target the CD20 antigen that’s present on the surface of certain cells, including the white blood cells known as B-lymphocytes, or B cells.2 Like Rituxan, Gazyva is a monoclonal antibody. That is, it…