Tislelizumab 100mg/10mL Injection — PD-1 Checkpoint Inhibitor for Esophageal and Gastric Cancers
Tevimbra® (Tislelizumab) — PD-1 Checkpoint Inhibitor Immunotherapy for Gastrointestinal Cancers
A Sourcing Guide for Hospitals and Oncology Centres
Tevimbra® (Tislelizumab) is a humanised IgG4 monoclonal antibody indicated, according to its approved prescribing information, for the treatment of esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (GEJ) adenocarcinoma, in various treatment settings including as a single agent and in combination with chemotherapy. As with all immuno-oncology therapies, the decision to prescribe Tevimbra, including PD-L1 biomarker testing where applicable, rests entirely with the treating oncologist, in accordance with the approved label. This page provides sourcing and procurement information for hospitals and pharmacies, not clinical or treatment guidance.
As both a trusted medicine distributor in Delhi and a licensed pharmaceutical distributor in Delhi, A.K. Pharma supplies genuine Tevimbra (Tislelizumab) 100mg/10mL to hospitals, oncology centres, and pharmacies across India.
Tevimbra contains Tislelizumab, a humanised monoclonal antibody that targets the programmed death-1 (PD-1) receptor, a key immune checkpoint protein expressed on T-cells.
PD-1 Checkpoint Signalling in Gastrointestinal Cancers:
According to published immuno-oncology literature, esophageal and gastric cancers frequently exploit the PD-1/PD-L1 pathway as a mechanism of immune evasion. Tumour cells expressing PD-L1 can bind PD-1 receptors on T-cells, delivering an inhibitory signal that suppresses the immune system’s ability to recognise and destroy the tumour. This is why PD-L1 expression testing is often used to help identify patients more likely to benefit from PD-1 inhibitor therapy in these cancer types.
Tislelizumab’s Distinguishing Mechanism: By binding to the PD-1 receptor, Tislelizumab blocks its interaction with PD-L1 and PD-L2, restoring T-cell activity against tumour cells, according to the manufacturer’s prescribing information. Published pharmacology data also notes that Tislelizumab was specifically engineered to minimise binding to Fc-gamma receptors on macrophages, a design intended to reduce a mechanism called antibody-dependent cellular phagocytosis that can otherwise deplete the very T-cells the therapy is meant to preserve and activate — a distinguishing structural feature compared to some other PD-1 inhibitors.
Full prescribing information is available at the FDA label for Tislelizumab, with additional background on gastrointestinal cancer immunotherapy available via the National Cancer Institute.
RATIONALE 302 Trial (Tislelizumab in Previously Treated ESCC)
Published in JAMA Oncology, the pivotal RATIONALE 302 trial randomised 512 patients with unresectable or metastatic ESCC to intravenous Tevimbra 200mg every 3 weeks or investigator’s choice of chemotherapy, following progression on prior systemic therapy. Key results demonstrated significantly improved overall survival with Tevimbra — a median of 8.6 months compared to 6.3 months with chemotherapy — along with a higher overall response rate, supporting its approval in this previously treated setting.
RATIONALE 306 Trial (Tislelizumab Plus Chemotherapy in First-Line ESCC)
This trial supported the expanded approval of Tevimbra in combination with platinum-containing chemotherapy for first-line treatment of ESCC in patients whose tumours express PD-L1, extending its use earlier in the treatment pathway for PD-L1 expressing disease.
RATIONALE 305 Trial (Tislelizumab Plus Chemotherapy in First-Line Gastric/GEJ Adenocarcinoma)
This global phase 3, randomised, placebo-controlled trial randomised 997 patients 1:1 to Tevimbra 200mg or placebo, both in combination with chemotherapy, supporting approval of Tevimbra for first-line treatment of HER2-negative, PD-L1 expressing gastric or gastroesophageal junction adenocarcinoma.
For broader clinical guidance on gastrointestinal cancer immunotherapy, the American Society of Clinical Oncology (ASCO) publishes ongoing treatment guidelines.
Tevimbra is supplied as:
| Presentation | Strength | Administration |
|---|---|---|
| Tevimbra Injection | 100mg/10mL (10mg/mL concentration) single-dose vial | Intravenous infusion |
Approved dosing regimens include 150mg every 2 weeks, 200mg every 3 weeks, or 300mg every 4 weeks, depending on the specific indication and combination regimen, as determined by the prescribing oncologist per the approved label.
Esophageal Squamous Cell Carcinoma (ESCC):
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma:
PD-L1 biomarker testing using an approved test is used to help guide treatment decisions for several of these indications, per the approved prescribing information.
For detailed indication information refer to MedlinePlus Tislelizumab.
Demonstrated Survival Benefit in Previously Treated ESCC
RATIONALE 302 demonstrated a significant overall survival improvement compared to chemotherapy in a population with limited prior treatment options, supporting Tevimbra’s role in previously treated ESCC.
Established First-Line Options Across Two GI Cancer Types
With approvals spanning both first-line ESCC and first-line gastric/GEJ adenocarcinoma in combination with chemotherapy, Tevimbra provides oncologists with treatment options across multiple points in the gastrointestinal cancer treatment pathway.
Engineered to Reduce Fc-Gamma Receptor Binding
Tislelizumab’s structural design, intended to minimise macrophage-mediated T-cell depletion, is a distinguishing pharmacological feature compared to certain other PD-1 inhibitors, according to the manufacturer’s published data.
Flexible Dosing Schedule Options
With approved dosing intervals of every 2, 3, or 4 weeks depending on the regimen, Tevimbra offers scheduling flexibility that oncologists can align with a patient’s broader treatment plan.
Dosing of Tevimbra is determined by the prescribing oncologist according to the approved label for the specific indication being treated. General administration information from the manufacturer’s prescribing information includes:
Monitoring (per manufacturer prescribing information):
Full dosing guidelines are available in the manufacturer’s official prescribing information and should always be followed exactly as directed by the treating oncologist.
Tevimbra is prescribed by oncologists for:
Tevimbra is prescribed by oncologists specialising in gastrointestinal malignancies. A.K. Pharma supplies Tevimbra to hospitals and oncology centres across Delhi and India.
Common side effects reported in clinical trials, when used in combination with chemotherapy, include nausea, fatigue, decreased appetite, anaemia, peripheral sensory neuropathy, vomiting, decreased platelet and neutrophil counts, elevated liver enzymes, diarrhoea, and decreased weight. As a single agent, commonly reported effects include increased blood glucose and decreased haemoglobin and lymphocyte counts.
Serious side effects include:
Immune-Mediated Adverse Reactions: As a class effect of checkpoint inhibitors, Tevimbra can cause immune-mediated inflammation affecting various organs, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and dermatologic reactions, as well as solid organ transplant rejection. These require prompt recognition and management per the approved prescribing information, which may include corticosteroid therapy and treatment interruption or discontinuation depending on severity.
Infusion-Related Reactions: Reported with intravenous administration; the infusion rate may be slowed, interrupted, or permanently discontinued based on severity, per standard oncology infusion protocols.
Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after Tevimbra treatment; specific precautions apply, addressed in the approved prescribing information.
Full side effect information is available at FDA Tislelizumab Safety Information.
As a responsible medicine distributor in Delhi, A.K. Pharma stores all oncology biologics including Tevimbra under manufacturer-recommended cold chain conditions ensuring product integrity for every supply.
Tevimbra (Tislelizumab) is manufactured by BeiGene, Ltd. Tislelizumab received its first FDA approval in March 2024 for previously treated ESCC, with subsequent expanded approvals for first-line ESCC and first-line gastric/GEJ adenocarcinoma. A.K. Pharma supplies only genuine Tevimbra sourced from authorised distributors.
Q. What is Tevimbra used for?
Tevimbra (Tislelizumab) is used to treat esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma, either as a single agent or in combination with chemotherapy, depending on the specific approved indication.
Q. What is the generic name and strength of Tevimbra?
The generic name of Tevimbra is Tislelizumab, supplied as a 100mg/10mL (10mg/mL) single-dose vial, manufactured by BeiGene.
Q. How is Tislelizumab different from other PD-1 inhibitors?
Tislelizumab was specifically engineered to minimise binding to Fc-gamma receptors on macrophages, a design intended to reduce macrophage-mediated depletion of the T-cells the therapy is meant to activate, according to the manufacturer’s published pharmacology data — a distinguishing structural feature compared to some other PD-1 inhibitors.
Q. Is PD-L1 testing required before starting Tevimbra?
For several of Tevimbra’s approved indications, PD-L1 expression testing using an approved test is used to help guide treatment decisions, per the current prescribing information. The specific testing requirement depends on which indication is being treated.
Q. Is Tevimbra available in India?
Tevimbra can be supplied to hospitals and oncology centres across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi and pharmaceutical distributor in Delhi — for availability and pricing.
Q. What is the price of Tevimbra in India?
Tevimbra price in India varies by order quantity. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.
Q. How to order Tevimbra from A.K. Pharma?
You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.
Q. Does A.K. Pharma supply Tevimbra in bulk?
Yes. A.K. Pharma supplies Tevimbra in bulk to hospitals and oncology centres across Delhi and India.
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Disclaimer: This page is intended for informational and sourcing/procurement purposes only and does not constitute medical or clinical advice. All treatment decisions, including drug selection and dosing, should be made by a qualified healthcare professional in accordance with the approved prescribing information. A.K. Pharma is a licensed medicine distributor and does not provide clinical guidance.
