Frequently Asked Questions

What is NHL?

Non-Hodgkin lymphoma (NHL) is not a single disease. It’s a general name used for a group of up to 30 related cancers of the lymphatic system. Doctors group the many different types of NHL by the kind of cells (called lymphocytes) that are not normal, how fast they grow, and how they affect the body. In general, B-cell lymphomas start from B-cells that are not normal, and T-cell lymphomas start from T-cells that are not normal.

Non-Hodgkin lymphoma can start in any part of the lymphatic system, a network or tissues and organs that makes and stores white blood cells to fight infection and disease. This includes the lymph nodes, special lymph organs such as the spleen, the bone marrow, which makes lymphocytes, or in the lymph tissue of organs such as the stomach or intestines. Because lymphocytes can go to virtually every part of the body through the lymphatic system, NHL often spreads to different parts of the body. In fact, NHL is often in more than one part of the body by the time it is found.

What are the symptoms of indolent B-cell NHL?

Indolent B-cell NHL is not easy to diagnose early because it is a slow-growing cancer. Sometimes it is found when a person goes for a routine checkup. Symptoms usually become more visible once the disease progresses and depend on where the cancer is in the body. Common symptoms include:

How is indolent B-cell NHL diagnosed?

Physical exam

Your doctor will check for swollen glands or lymph nodes.

Biopsy

A biopsy can help determine if abnormal cells are in lymph nodes or other lymph tissues. A biopsy is the only way to be sure it is NHL. It also finds chromosomal abnormalities, and shows if it is a B-cell or T-cell lymphoma.

Blood test

A blood test assesses your white blood counts and a substance called LDH (or lactate dehydrogenase), which can be raised by NHL. This is done by looking at blood cells under a microscope.

Imaging

Imaging tests, such as a CT scan, MRI, and PET scan, can check for swollen lymph nodes or other signs of NHL.

What are the stages of indolent B-cell NHL?

Based on your tests, your doctor will rank your disease in one of the following stages:

In addition, your doctor may use the letters A, B, or E to further label the stage of NHL.

• A means no symptoms are present (eg, fever, chills, night sweats, itching, and weight loss)
• B means symptoms such as fever, chills, night sweats, itching, and weight loss are present
• E means involvement of a part of your body other than the lymph nodes

What are the treatment options?

There are many choices for treating indolent B-cell NHL. If one kind of treatment does not work, or if it works for a while and then the disease returns, your doctor may change to a different treatment.

The treatment choices may include:

Chemotherapy: A cancer treatment that uses drugs to stop the growth of cancer cells, either by killing the cells, or by stopping them from increasing in number.

Biologic therapy: A type of treatment that works with your immune system. Monoclonal antibody therapy is one type of biologic therapy used to treat NHL. It can help the immune system kill lymphoma cells.

Radiation therapy: A treatment that uses high-energy X-rays or other types of radiation to kill cancer cells and keep them from growing.

What is the goal of treatment?

The goal of any treatment for indolent B-cell NHL is to reduce or eliminate the presence of indolent B-cell NHL cells in the blood and bone marrow.

What is TREANDA?

TREANDA is a chemotherapy that has been shown to kill cells that cause indolent B-cell NHL. TREANDA has a chemical structure that may help it kill cancer cells in many different ways. The exact way that TREANDA kills cells remains unknown.

In a clinical study, 100 patients received TREANDA without it being combined with another drug. The study included patients who were diagnosed with a form of indolent B-cell NHL and who had received prior treatment with rituximab or a rituximab-containing regimen and whose disease progressed during or within 6 months of treatment. Seventy-four percent of patients showed an overall response (this includes patients who showed a complete response or partial response) when TREANDA was used alone in patients with indolent B-cell NHL.

The most common non-blood-related side effects (occurring in ≥15% of patients) with TREANDA are nausea, fatigue, vomiting, diarrhea, pyrexia (fever), constipation, anorexia (loss of appetite), cough, headache, weight decreased, dyspnea (difficulty breathing), rash, and stomatitis (inflammation of the mouth). The most common blood-related abnormalities (occurring in ≥15% of patients) with TREANDA include decreased lymphocyte cells (lymphopenia), decreased white blood cells (leukopenia), decreased red blood cells (anemia), and decreased neutrophils (neutropenia). and decreased platelets (thrombocytopenia).

What is TREANDA indicated for?

TREANDA is a chemotherapy approved by the Food and Drug Administration (FDA) to treat patients with indolent B-cell NHL that has progressed or spread during or within 6 months of rituximab or a rituximab-containing regimen.

Please see below for the Important Safety Information for TREANDA.

How is TREANDA given to treat indolent B-cell NHL that has spread or progressed?

TREANDA is usually given through a needle that is put into your vein. This is called an intravenous (IV) infusion. The infusion lasts for 60 minutes and is given on Days 1 and 2 of each 21-day treatment cycle. TREANDA may be given for up to 8 cycles. Your doctor may need to adjust your dosing schedule if you experience side effects.

What can be expected after treatment with TREANDA?

After treatment with TREANDA, some patients may have no signs of indolent B-cell non-Hodgkin's lymphoma in their blood. This is called a complete response. Other patients may have a lower number of indolent B-cell NHL cells or fewer symptoms. This is called a partial response. Some patients may have no response to this treatment. The total number of patients with complete response and partial response is known as the overall response rate.

The most common non-blood-related side effects (occurring in ≥15% of patients) with TREANDA include fever, nausea, and vomiting. The most common blood-related abnormalities (occurring in ≥15% of patients) with TREANDA include decreased lymphocyte cells (lymphopenia), decreased red blood cells (anemia), decreased white blood cells (leukopenia), decreased platelets (thrombocytopenia), and decreased neutrophils (neutropenia).

What are the results of treatment with TREANDA?

TREANDA showed a high overall response rate when used alone in a clinical study. The overall response was 74% for patients whose disease spread or progressed during or within 6 months after treatment with rituximab or a rituximab-containing regimen.

In a clinical study, TREANDA was not compared to or combined with additional treatments. A total of 100 patients received TREANDA. The study included patients who were diagnosed with a form of indolent B-cell NHL. They had also already been treated with rituximab or a combination of treatments that included rituximab and their disease progressed during treatment or within 6 months of stopping it.

There was a lasting response in patients receiving TREANDA. In this study, the median duration of response was 9.2 months for patients taking TREANDA.

"Median" is the number where half of the patients experienced higher duration of response and half experienced lower duration of response.

What side effects may occur while I am taking TREANDA?

When chemotherapies kill cancer cells, they can also affect healthy blood cells. These healthy cells include red blood cells, platelets, and white blood cells. Some of the most common side effects happen when the number of healthy cells goes down. Please talk to your healthcare provider about the possible risks of side effects, which may include:

Allergic reactions: There is the possibility of mild or serious allergic reactions with TREANDA. Immediately report rash, facial swelling, or difficulty breathing during or soon after infusion because these symptoms may become severe or even life-threatening.

Myelosuppression: TREANDA may cause a decrease in white blood cells, platelets, and red blood cells. You will need frequent monitoring of your blood cells. Report shortness of breath, significant tiredness, bleeding, fever, or other signs of infection to your doctor because these symptoms may be severe and even life-threatening.

Pregnancy and nursing TREANDA can cause harm to a fetus. Women should avoid becoming pregnant throughout treatment and for 3 months after TREANDA therapy has stopped. Men receiving TREANDA should use reliable contraception (birth control) throughout treatment and for 3 months after TREANDA therapy has stopped. Report pregnancy immediately. Avoid nursing while receiving TREANDA.

Fatigue: TREANDA may cause tiredness. Avoid driving any vehicle or operating any dangerous tools or machinery if you experience this side effect.

Nausea and vomiting: TREANDA may cause nausea and/or vomiting. You should report nausea and vomiting so that you can get treatment for these symptoms.

Diarrhea: TREANDA may cause diarrhea. You should report diarrhea to your healthcare provider so that it can be treated.

Rash: A mild rash or itching may occur during treatment with TREANDA. Immediately report severe or worsening rash or itching to your doctor.

Serious side effects have been associated with TREANDA, including myelosuppression (a reduced ability for the body to produce blood cells), infections, fever, chills, itching and severe allergic reaction, tumor lysis syndrome (rapid destruction of cancer cells), skin reactions including SJS/TEN, new cancers, and extravasation (drug escape from the vein during administration).

Some side effects, such as myelosuppression, infections, and SJS/TEN (when TREANDA was given at the same time as allopurinol and other medications known to cause SJS/TEN), have caused death. Your doctor will check you closely for these side effects and treat you quickly if they occur.

Some side effects may lead to the dose of TREANDA being lowered, stopped, or delayed.

TREANDA is not for patients with an allergy to bendamustine or mannitol. Women should be not become pregnant while using TREANDA.

The most common side effects associated with TREANDA (frequency ≥15%) not related to blood are nausea, fatigue, vomiting, diarrhea, pyrexia (fever), constipation, loss of appetite, cough, headache, weight decreased, dyspnea (difficulty breathing), rash, and stomatitis (inflammation of the mouth). The most common side effects associated with TREANDA (frequency ≥15%) related to blood are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.

Please see full Prescribing Information.

How will my healthcare professional monitor me during treatment with TREANDA?

Your healthcare professional will ask you to have blood drawn to see how you respond to treatment. You may have your dose or medications changed based on the results of this testing. These blood tests will show if you have low red blood cells, low white blood cells, and/or low platelets.

• Low red blood cells may make you feel tired, get tired easily, look pale, and become short of breath
• Low white blood cells may make it easier for you to get an infection. If you have a fever or other signs of infection, such as chills and coughing, call your doctor right away
• Low platelets can make it easier for you to bleed. Call your doctor if you have any unusual bleeding

You can help with your treatment by keeping track of your side effects and blood counts (after testing and during doctor visits) with the TREANDA Treatment Diary.

How do I know if TREANDA is working?

While you are taking TREANDA, your healthcare team will want you to have physical exams, imaging tests (such as CT or PET scans), and lab tests to measure your progress. They will know that TREANDA is working if they see fewer indolent B-cell NHL cells on these tests.

Track your progress with the TREANDA Treatment Diary by writing down your blood counts and other notes.