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What are ALL and LBL?

Help guide the understanding of blood cancers known as ALL and LBL.

Hello. I am one of the bone marrow cells. My job is to develop into the cells that make the body perform its many functions.

Sometimes, bone marrow cells don't develop as they should. I will explain how this can lead to blood cancer.

There are many different types of blood cancers, but today we will focus on 2—acute lymphoblastic leukemia, or ALL, and lymphoblastic lymphoma, or LBL.

Our topics include how rare these blood cancers are and the role of asparaginase in treating them.

Leukemia is a broad term for cancer of the blood cells. Let's look at how normal blood is different from leukemia blood. In a healthy person, white blood cells called lymphocytes mature and help the body fight infection.

ALL and LBL are similar forms of blood cancer — can affect white blood cells, red blood cells, and platelets—but there are key differences.

ALL and LBL are caused when lymphoblasts, which are immature white blood cells, fail to mature into fully formed white blood cells called lymphocytes.

Blood cancer develops when immature lymphoblasts malfunction…and grow out of control.

An important difference between ALL and LBL is where the cancer cells are commonly found.

ALL affects white blood cells and platelets in the bone marrow.

LBL also affects the white blood cells, but does not start in the bone marrow. Parts of the body affected by LBL early on include glands such as the thymus and lymph nodes.

LBL is also extremely aggressive and can spread to other parts of the body very quickly.

In ALL and LBL, leukemia and lymphoma cells grow faster than healthy blood cells. So when these cells spread out of control, they can quickly outnumber the healthy cells your body needs.

How often do people get ALL and LBL?

ALL is a rare cancer. An estimated 6540 people in the US will be diagnosed with ALL in 2023, which is less than 1 percent of all new cancer cases.

While rare, ALL is the most common type of cancer in children. More than 53% of the patients with ALL are 19 years old or younger.

LBL is an even rarer cancer. An estimated 1600 people in the US will be diagnosed with LBL in 2023.

For ALL and LBL, an important treatment goal is removing a molecule called asparagine from a patient’s blood. Both healthy cells and cancer cells need asparagine to survive.

Asparagine is usually found inside the cells of the body, but it is also found in the blood stream.

Healthy cells can create their own asparagine, but cancer cells cannot.

Cancer cells need to get asparagine from blood to survive.

Asparaginase is a naturally occurring protein in the body that breaks down asparagine in blood.

Doctors use asparaginase as a medicine to treat ALL and LBL to break down asparagine in the blood, which causes cancer cells to die.

Asparaginase is just 1 part of a multi-drug treatment for ALL and LBL. Studies show that patients with high-risk B-cell ALL who received all of their asparaginase doses were less likely to have their disease return compared to patients who missed 1 or more asparaginase doses.

It is important to know that there are 2 types of asparaginase therapy approved in the US.

The first type is asparaginase derived from Escherichia coli, or E. coli.

The second type of asparaginase is derived from Erwinia chrysanthemi and is used when a patient has an allergic reaction to E. coli asparaginase.

We hope that this video gives you a better understanding of ALL and LBL and the role of asparaginase in the treatment of these conditions.

To learn more, talk to your healthcare team. They can address your questions or concerns and support you in making the best care decisions for you or your child.

Indication

RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen given by intramuscular injection for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

IMPORTANT SAFETY INFORMATION

Contraindications

RYLAZE is contraindicated in patients with:

  • History of serious hypersensitivity reactions to Erwinia asparaginase, including anaphylaxis
  • History of serious pancreatitis during previous asparaginase therapy
  • History of serious thrombosis during previous asparaginase therapy
  • History of serious hemorrhagic events during previous asparaginase therapy
  • Severe hepatic impairment

Warnings and Precautions

Hypersensitivity Reactions

Hypersensitivity reactions after the use of RYLAZE occurred in 29% of patients in clinical trials, and it was severe in 6% of patients. Anaphylaxis was observed in 2% of patients after intramuscular administration. Discontinuation of RYLAZE due to hypersensitivity reactions occurred in 5% of patients. Hypersensitivity reactions were higher in patients who received intravenous asparaginase erwinia chrysanthemi (recombinant)-rywn. The intravenous route of administration is not approved.

In patients administered RYLAZE intramuscularly in clinical trials, the median number of doses of RYLAZE that patients received prior to the onset of the first hypersensitivity reaction was 12 doses (range: 1-64 doses). The most commonly observed reaction was rash (19%), and 1 patient (1%) experienced a severe rash.

Hypersensitivity reactions observed with L-asparaginase class products include angioedema, urticaria, lip swelling, eye swelling, rash or erythema, blood pressure decreased, bronchospasm, dyspnea, and pruritus.

Premedicate patients prior to administration of RYLAZE as recommended. Because of the risk of serious allergic reactions (e.g., life-threatening anaphylaxis), administer RYLAZE in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g., epinephrine, oxygen, intravenous steroids, antihistamines). Discontinue RYLAZE in patients with serious hypersensitivity reactions.

Pancreatitis

Pancreatitis, including elevated amylase or lipase, was reported in 20% of patients in clinical trials of RYLAZE and was severe in 8%. Symptomatic pancreatitis occurred in 7% of patients, and it was severe in 6% of patients. Elevated amylase or lipase without symptomatic pancreatitis was observed in 13% of patients treated with RYLAZE. Hemorrhagic or necrotizing pancreatitis have been reported with L-asparaginase class products.

Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Evaluate patients with symptoms compatible with pancreatitis to establish a diagnosis. Assess serum amylase and lipase levels in patients with any signs or symptoms of pancreatitis. Discontinue RYLAZE in patients with severe or hemorrhagic pancreatitis. In the case of mild pancreatitis, withhold RYLAZE until the signs and symptoms subside and amylase and/or lipase levels return to 1.5 times the ULN. After resolution of mild pancreatitis, treatment with RYLAZE may be resumed.

Thrombosis

Serious thrombotic events, including sagittal sinus thrombosis and pulmonary embolism, have been reported in 1% of patients following treatment with RYLAZE. Discontinue RYLAZE for a thrombotic event, and administer appropriate antithrombotic therapy. Consider resumption of treatment with RYLAZE only if the patient had an uncomplicated thrombosis.

Hemorrhage

Bleeding was reported in 25% of patients treated with RYLAZE, and it was severe in 2%. Most commonly observed reactions were bruising (12%) and nose bleed (9%).

In patients treated with L-asparaginase class products, hemorrhage may be associated with increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy.

Hepatotoxicity, including Hepatic Veno-Occlusive Disease

Elevated bilirubin and/or transaminases occurred in 75% of patients treated with RYLAZE in clinical trials, and 26% had Grade ≥3 elevations. Elevated bilirubin occurred in 28% of patients treated with RYLAZE in clinical trials, and 2% had Grade ≥3 elevations. Elevated transaminases occurred in 73% of patients treated with RYLAZE in clinical trials, and 25% had Grade ≥3 elevations.

Hepatotoxicity, including severe, life-threatening, and potential fatal cases of hepatic veno-occlusive disease (VOD), have been observed in patients treated with asparaginase class products in combination with standard chemotherapy, including during the induction phase of multiphase chemotherapy. Do not administer RYLAZE to patients with severe hepatic impairment.

Evaluate bilirubin and transaminases prior to each cycle of RYLAZE and at least weekly during cycles of treatment that include RYLAZE, through four weeks after the last dose of RYLAZE. Monitor frequently for signs and symptoms of hepatic VOD, which may include rapid weight gain, fluid retention with ascites, hepatomegaly (which may be painful), and rapid increase of bilirubin. For patients who develop abnormal liver tests after RYLAZE, more frequent monitoring for liver test abnormalities and clinical signs and symptoms of VOD is recommended. In the event of serious liver toxicity, including VOD, discontinue treatment with RYLAZE and provide supportive care.

Adverse Reactions

The most common adverse reactions (incidence >20%) with RYLAZE are abnormal liver test, nausea, musculoskeletal pain, infection, fatigue, headache, febrile neutropenia, pyrexia, hemorrhage, stomatitis, abdominal pain, decreased appetite, drug hypersensitivity, hyperglycemia, diarrhea, pancreatitis, and hypokalemia.

Use in Specific Populations

Pregnancy and Lactation

RYLAZE can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with RYLAZE and for 3 months after the last dose. Advise women not to breastfeed during treatment with RYLAZE and for 1 week after the last dose.

Please see full Prescribing Information.

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Indication

RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen given by intramuscular injection for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY 
INFORMATION AND INDICATION

Contraindications

RYLAZE is contraindicated in patients with:

  • History of serious hypersensitivity reactions to Erwinia asparaginase, including anaphylaxis
  • History of serious pancreatitis during previous asparaginase therapy
  • History of serious thrombosis during previous asparaginase therapy
  • History of serious hemorrhagic events during previous asparaginase therapy
  • Severe hepatic impairment
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