What is it used for?
AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on objective response rate (ORR) . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on objective response rate (ORR) . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Read the primary sourceThis source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.
Product details
- Active ingredient
- lifileucellifileucel
- Form and strength
- SUSPENSION · 72000000000 1 / 500 mLSUSPENSION · 72000000000 1 / 500 mL
- Manufacturer / applicant
- IOVANCE BIOTHERAPEUTICS INC.IOVANCE BIOTHERAPEUTICS INC.
AMTAGVI is a cell suspension for intravenous infusion. A single dose of AMTAGVI contains 7.5 × 10 9to 72 × 10 9viable cells suspended in a cryopreservation medium. A single dose is split into 1 to 4 patient-specific …AMTAGVI is a cell suspension for intravenous infusion. A single dose of AMTAGVI contains 7.5 × 10 9to 72 × 10 9viable cells suspended in a cryopreservation medium. A single dose is split into 1 to 4 patient-specific …
Safety and clinical review
Monitor patients for prolonged severe cytopenia and monitor for internal organ hemorrhage . Administer filgrastim or a biosimilar product to patients beginning Day 1 after AMTAGVI and continuing daily until the absolute neutrophil count (ANC) is greater than 1000 per mm 3for …Monitor patients for prolonged severe cytopenia and monitor for internal organ hemorrhage . Administer filgrastim or a biosimilar product to patients beginning Day 1 after AMTAGVI and continuing daily until the absolute neutrophil count (ANC) is greater than 1000 per mm 3for …
- Treatment-Related MortalityTreatment-Related Mortality
- Prolonged Severe CytopeniaProlonged Severe Cytopenia
- Internal Organ HemorrhageInternal Organ Hemorrhage
- Severe InfectionSevere Infection
- Cardiac DisorderCardiac Disorder
- Respiratory FailureRespiratory Failure
Ask your clinician to review the complete label, medical history, other medicines, allergies, pregnancy or breastfeeding and any required monitoring. Do not start, stop or change treatment from this page.
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Include the brand or generic name, strength, dosage form, requested quantity and country where care is needed. You can attach a prescription when you continue.
Questions patients ask
What is AMTAGVI used for?
AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on objective response rate (ORR) . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on objective response rate (ORR) . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
This source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.
Which formulation of AMTAGVI should I ask about?
SUSPENSION · 72000000000 1 / 500 mLSUSPENSION · 72000000000 1 / 500 mL
Read the primary sourceWhat determines the price of AMTAGVI?
A current quote depends on the exact presentation, quantity, provider and access arrangements. A catalogue entry is not a stock or delivery promise. Medical charges are paid to the provider, separately from coordination fees.
What should I check before using AMTAGVI?
Ask your clinician to review the complete label, medical history, other medicines, allergies, pregnancy or breastfeeding and any required monitoring. Do not start, stop or change treatment from this page.
Sources and review scope
This source does not establish current stock, import permission or personal eligibility in China. The treating clinician and provider must confirm these separately.