Tevimbra (tislelizumab) injection

Tevimbra  is a formulation of  Tislelizumab, a monoclonal antibody used primarily in cancer immunotherapy. It is designed to treat various types of cancer by enhancing the body’s immune response against tumor cells. Tislelizumab was developed by BeiGene, a global biotechnology company, and is part of the class of drugs known as immune checkpoint inhibitors. These drugs work by targeting specific proteins that allow cancer cells to evade the immune system.

How It Works

Tevimbra functions by targeting and blocking the programmed death-1 (PD-1) receptor, a critical checkpoint in the immune system’s ability to recognize and destroy cancer cells. Here’s a detailed explanation of its mechanism of action: 1. **Immune Checkpoint Inhibition**: – Tislelizumab is a humanized IgG4 monoclonal antibody that specifically binds to the PD-1 receptor on T-cells. The PD-1 receptor is an immune checkpoint that, when engaged by its ligands PD-L1 and PD-L2, inhibits T-cell activation and proliferation. 2. **Blocking PD-1/PD-L1 Interaction**: – By blocking the interaction between PD-1 and its ligands, Tislelizumab prevents the inhibitory signals that normally dampen the immune response. This allows T-cells to remain active and continue attacking cancer cells. 3. **Enhanced T-cell Activation**: – The blockade of PD-1 leads to increased activation of T-cells, enhancing the immune system’s ability to recognize and destroy tumor cells. This helps to slow or halt the progression of the cancer. 4. **Anti-Tumor Immune Response**: – By reactivating the body’s natural immune response, Tevimbra promotes the infiltration of T-cells into tumors, leading to a more robust anti-tumor response. This can result in tumor shrinkage and improved clinical outcomes for patients with certain types of cancer. 5. **Overcoming Immune Evasion**: – Many cancers exploit the PD-1/PD-L1 pathway to evade the immune system. By inhibiting this pathway, Tevimbra helps to overcome this immune evasion, allowing the immune system to effectively target and eliminate cancer cells.

Indications

Tevimbra is indicated for the treatment of various types of cancer. Some of the primary indications include:

• Non-Small Cell Lung Cancer (NSCLC):
  • Tislelizumab is approved for the treatment of patients with advanced or metastatic NSCLC, either as monotherapy or in combination with chemotherapy.
• Hodgkin Lymphoma:
  • Tevimbra is indicated for the treatment of adult patients with relapsed or refractory classic Hodgkin lymphoma (cHL) who have received at least two prior therapies.
• Esophageal Squamous Cell Carcinoma (ESCC):
  • Approved for use in patients with advanced or metastatic ESCC who have progressed after prior systemic therapy.
• Urothelial Carcinoma:
  • Tislelizumab is used for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
• Other Cancers:
  • Tislelizumab is under investigation and may be used off-label for other cancers, such as liver cancer, gastric cancer, and more, depending on clinical trials and regulatory approvals.

Side Effects

Like other monoclonal antibodies targeting immune checkpoints, Tevimbra can cause a range of side effects, from mild to severe. Here are some common and serious side effects associated with its use:

• Common Side Effects:
  • Fatigue
  • Rash
  • Itching
  • Nausea
  • Diarrhea
  • Cough
  • Fever
  • Decreased appetite
  • Muscle or joint pain
• Serious Side Effects:
  • **Immune-Mediated Adverse Reactions**:
    • **Pneumonitis**: Inflammation of the lungs can occur, leading to symptoms such as cough, shortness of breath, and chest pain. This condition requires immediate medical attention.
    • **Colitis**: Inflammation of the colon may present with diarrhea, abdominal pain, and bloody stools.
    • **Hepatitis**: Liver inflammation can lead to elevated liver enzymes, jaundice, and abdominal pain.
    • **Endocrinopathies**: Inflammation of hormone-producing glands, such as the thyroid, pituitary, and adrenal glands, can cause a variety of symptoms, including fatigue, weight changes, and mood alterations.
    • **Nephritis**: Kidney inflammation may result in decreased kidney function and changes in urine output.
    • **Severe Infections**: Some patients may experience severe infections requiring hospitalization, including bacterial, viral, or fungal infections.
  • **Infusion-Related Reactions**: Symptoms can include fever, chills, difficulty breathing, flushing, and dizziness during or after the infusion.

Contraindications

Tevimbra is contraindicated in the following scenarios:

• Hypersensitivity: Patients with a known hypersensitivity to tislelizumab or any of its components should not use Tevimbra.
• Severe Allergic Reactions: Individuals who have experienced severe or life-threatening hypersensitivity reactions to monoclonal antibodies should avoid using Tevimbra unless appropriate medical supervision is available.
• Pregnancy: Tislelizumab is contraindicated during pregnancy due to potential harm to the developing fetus. Women of childbearing potential should use effective contraception during treatment and for a certain period after the last dose.
• Active Infections: Patients with active, untreated infections, especially those requiring systemic antimicrobial therapy, should not receive Tevimbra until the infection is adequately controlled.

Pricing Information

Below is a table detailing the price of Tevimbra in various countries. Please note that prices may vary depending on the healthcare system, availability, and dosage requirements.

Country	Price (per dose)	Reference
United States	$6,000 – $8,000	GoodRx
United Kingdom	£4,500 – £6,000	NHS
Australia	AUD $8,500 – $10,000	PBS
Canada	CAD $7,000 – $9,000	DrugBank
Germany	€5,500 – €7,500	Apotheken Umschau

Top 5 Global Brands

Several pharmaceutical companies produce monoclonal antibody therapies targeting immune checkpoints. Here are some of the top global brands:

• Opdivo (Nivolumab) – Bristol-Myers Squibb
• Keytruda (Pembrolizumab)