BLINCYTO

BLINCYTO is an immunotherapy treatment specifically designed to combat Acute Lymphoblastic Leukemia (ALL). Unlike traditional chemotherapy, BLINCYTO operates by collaborating with the body’s immune system to locate and eliminate cancerous cells.

If you or your child experience any changes in urination frequency or amount, muscle or joint pain, rapid weight gain, swelling in the feet or lower legs, or unusual fatigue or weakness, it is important to contact your doctor immediately. It is possible for pancreatitis to occur while taking this medication.

The treatment course for BLINCYTO consists of 1 cycle for induction and up to 3 additional cycles for consolidation. Each cycle consists of 28 days of continuous intravenous infusion, followed by a 14-day treatment-free interval, resulting in a total of 42 days per cycle.

In the past, it was uncommon for children to survive childhood leukemia. However, thanks to advancements in treatment, the situation has significantly improved. Currently, children with the disease have a survival rate of up to 90%, allowing them to lead fulfilling and successful lives.

The 5-year survival rates for different types of leukemia are as follows:
– Acute lymphocytic leukemia (ALL): 71.3%
– Chronic myeloid leukemia (CML): 70.6%
– Acute myeloid leukemia (AML): 31.7%
– Acute monocytic leukemia (AML-M5): 23.7%

BLINCYTO® is an immunotherapy that combats acute lymphoblastic leukemia (ALL) by working in conjunction with the immune system to locate and eliminate cancer cells, distinguishing it from chemotherapy.

The 2023 American Society of Hematology (ASH) annual meeting and exhibition featured a study that has been hailed as setting a new standard for chronic lymphocytic leukemia (CLL) treatment. The study’s findings demonstrated the effectiveness of tailoring the duration of treatment, specifically with the combination of ibrutinib and venetoclax.

During treatment, blood tests may be conducted regularly to monitor your condition. Depending on the results of these tests and any other side effects, the dosage and timing of your treatment may be adjusted. It seems that consuming alcohol in small quantities does not impact the safety or effectiveness of blinatumomab.

Immunotherapy and chemotherapy are both utilized as cancer treatments, but they differ in their approach to targeting cancer cells. Chemotherapy employs drugs to specifically target and eliminate rapidly dividing cells, while immunotherapy harnesses the body’s immune system to impede, halt, and eradicate cancerous cells.

The study findings indicated that patients who were administered blinatumomab in addition to chemotherapy during the consolidation phase experienced significantly improved outcomes. Their overall survival rate was 83%, whereas patients who only received consolidation chemotherapy had a survival rate of 65%.

Blinatumomab, classified as a bispecific T-cell engager antibody, is utilized in both adults and children to treat ALL that is in remission, where there is still some evidence of the cancer present.

For adult patients, it is recommended to administer 20 mg of dexamethasone intravenously one hour before starting each cycle of BLINCYTO therapy. For pediatric patients, an oral or intravenous dose of 10 mg/m2 (not exceeding 20 mg) of dexamethasone should be given 6 to 12 hours before the start of BLINCYTO on cycle 1, day 1.

Patients may exhibit mild symptoms such as headaches, fatigue, confusion, drowsiness, or disorientation. In more severe cases, they may experience problems with coordination, seizures, difficulty speaking, or a state of unconsciousness. Neurotoxicity symptoms typically arise within a week after receiving a blinatumomab infusion.

The price of a single-dose vial of Blincyto (blinatumomab) is around $5,169 for 35 micrograms (mcg). However, this cost may differ depending on factors such as your insurance coverage, clinic expenses, and any additional fees for administration and facility use.

Blincyto is the brand name for the generic drug blinatumomab. It is available in the form of a lyophilized powder for intravenous infusion after reconstitution. Each vial contains 35mcg of blinatumomab and does not contain any preservatives.

Immunotherapy, while only used by 12.1% of patients, accounts for 36.2% of all spending on oncology medications. The average cost per patient for immunotherapy is five times higher than for other anticancer therapies.

BLINCYTO® is administered through a continuous intravenous (IV) infusion, where the medication is delivered directly into your bloodstream through a vein. This treatment method is carried out over a span of 4 weeks.

David M. Reese, M.D., executive vice president of Research and Development at Amgen, expressed his satisfaction with the FDA’s decision to grant full approval for BLINCYTO. He highlighted that BLINCYTO is not only the first FDA-approved CD19-directed CD3 T-cell engager BiTE® immunotherapy, but also the first to be approved for MRD in 2018.

Blinatumomab, a monoclonal antibody, has the potential to disrupt the growth and metastasis of cancer cells.

The price of a 4 milliliter supply of Opdivo intravenous solution (10 mg/mL) can vary, but it is typically around $1,297 at different pharmacies.

Size | Price | Quantity
——–|——-|———-
5mg | USD 1270 | 1 2 3 4 5 6 7 8 9 10
25mg | USD 4270 | 1 2 3 4 5 6 7 8 9 10
100mg | USD 8900 | 1 2 3 4 5 6 7 8 9 10
1g | USD 16700 | 1 2 3 4 5 6 7 8 9 10

After 3.5 years, the survival rate of patients who received blinatumomab and chemotherapy was 83%, while only 65% of patients who received chemotherapy alone were still alive.

Neutropenia is a frequent occurrence when undergoing BLINCYTO® treatment and can potentially be life-threatening. Having low white blood cell counts can heighten the chances of developing an infection. Throughout your BLINCYTO® treatment, your healthcare provider will conduct blood tests to monitor your white blood cell counts.

After 3.5 years of postremission therapy, the survival rate for patients treated with blinatumomab and chemotherapy was 83%, while the survival rate for those treated with chemotherapy alone was 65%.

The EFS benefit was observed in all pre-defined subgroups, including patients who experienced a relapse within 18 months of diagnosis or had extramedullary disease. This benefit is likely due to improved systemic control, although it is worth noting that blinatumomab can cross the blood-brain barrier and low levels of the drug have been found in the cerebrospinal fluid.

It is recommended to promptly initiate dexamethasone at a dosage of 0.2-0.4 mg/kg/d, with a maximum of 24 mg, divided into three doses per day for a duration of 1-3 days, in cases of severe neurotoxicity. If a patient experiences more than one seizure, any grade 4 neurotoxicity, or if neurologic recovery is delayed for more than 7 days, blinatumomab should be permanently discontinued.

In conclusion, blinatumomab has shown to be effective in reducing disease burden with fewer side effects compared to standard chemotherapeutics. This makes it a potential viable option for patients with high-disease burden before CAR-T cell therapy, without compromising efficacy. However, more research is needed to fully understand its effectiveness.

Blincyto is indicated for the treatment of relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) in patients aged one year and older.

Company: Amgen Inc. is a multinational biopharmaceutical company that specializes in the development and manufacturing of innovative therapies for serious illnesses.

The dosage contents may pose a health hazard if there is significant absorption, such as inhalation after a major spill or leak. It is important to avoid inhaling, making skin contact, getting it in the eyes, and accidental ingestion. However, it does not meet the classification criteria of the Globally Harmonized System (GHS) and therefore is not classified.

Patients receiving BLINCYTO® may experience Cytokine Release Syndrome (CRS), which can be severe and potentially fatal. It is advised to interrupt or stop the use of BLINCYTO® and administer corticosteroids as prescribed to manage this condition.

The treatment course includes one cycle for induction and up to three additional cycles for consolidation. Each cycle of BLINCYTO® induction or consolidation treatment lasts for 28 days of continuous intravenous infusion, followed by a 14-day break from treatment (totaling 42 days).

DateArticleDec 3, 2014
FDA Approves Blincyto (blinatumomab) for Precursor B-Cell Acute Lymphoblastic Leukemia

Oct 9, 2014
FDA Grants Priority Review Designation to Amgen’s BiTE® Immunotherapy Blinatumomab for Acute Lymphoblastic Leukemia

Blincyto (blinatumomab) – The FDA has decided that the REMS requirement is no longer needed and has therefore removed it. Imfinzi (durvalumab) – The Medication Guide has been revised in general.